510(k) Report

510(k) · Cleared

Cleared

Reprocessed Soft Tissue Ablators

K012631510(k) TraditionalCleared Dec 6, 2001115-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alliance Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 6, 2001 as substantially equivalent to K000036 (Arthrocare Corp., 2000) and 22 other predicates after a 115-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.

Decided
Dec 6, 2001
Review
115 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
23

Its longest line of descent runs back 7 generations to K943450 (1995). 33 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 8 other ancestors1999: 3 other ancestors1998: 2 other ancestors1997: 1 other ancestor1996: 5 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1985: 1 other ancestor1980: 1 other ancestor2006: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K992180 · Visage Cosmetic Surgery, Model V5000 · Arthrocare Corp. · 200019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 10 other ancestors 1 generation forward: 1 descendant K992180 · Visage Cosmetic Surgery, Model V5000 · Arthrocare Corp. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−50
  1. Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 3 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 2 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 1 generation backK992180 Visage Cosmetic Surgery, Model V5000Arthrocare Corp. · 2000
  8. This deviceK012631 Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  9. Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−6K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−5K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−4K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−3K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−2K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−1K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.2000—
0 (this device)K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.2001—
+1K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199220
199410
199520
199650
199710
199820
199930
200080

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K012631, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (23)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K000036Entec Reflex Wand 55, Model E4055-00
Summary page 2
…End Effect Electrode (21°, 3.5mm) 225304 Mitek® VAPR™ 90° Hook Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K96378…
Arthrocare Corp.2000—
*K000044Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spinewands
Summary page 2
…5mm) 225304 Mitek® VAPR™ 90° Hook Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K97…
Arthrocare Corp.2000—
*K000074Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Plasma Scalpel GS…
Summary page 2
…04 Mitek® VAPR™ 90° Hook Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981…
Arthrocare Corp.2000—
*K000228Entec Controller, Entec Patient Cable, Footswitch, Powercord, Plasma Wand
Summary page 2
…® VAPR™ 90° Hook Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992…
Arthrocare Corp.2000—
*K000511Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…
Summary page 2
…90° Hook Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992…
Arthrocare Corp.2000—
*K000936Vapr 2.3MM Wedge Electrode for Use with Vapr System
Summary page 2
…Electrode (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992…
Mitek Products2000—
*K001302Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…
Summary page 2
…de (3.5mm) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K99…
Arthrocare Corp.2000—
*K001936Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord
Summary page 2
…m) 225305 Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 Ar…
Arthrocare Corp.2000—
*K943450Arthrocare Arthroscopic Electrosurgery System Model 970
Summary page 2
…Mitek® VAPR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare,…
Arthrocare Corp.1995—
*K955531Arthrocare Bipolar Loop Electrode System
Summary page 2
…APR™ Flexible Side Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCa…
Arthrocare Corp.1996—
*K961069Arthrocare Urologic Multi-Electrode Electrosurgery System
Our OCR of the scanned summary read K960169, FDA’s number for Carbomedics Valve Tester (Carbomedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ArthroCare® Urologic Multi-electrode Electrosurgery System”.
Arthrocare Corp.1996—
*K962445Arthrocare Dental Electrosurgery System
Summary page 2
…e Effect Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex…
Arthrocare Corp.1996—
*K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)
Summary page 2
…Electrode (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand A…
Arthrocare Corp.1996—
*K963783Mitek Electrosurgical System for Arthroscopic Use
Summary page 2
…e (3.5mm) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare…
ETHICON, Inc.1996—
*K964849Arthrocare Dermatologic Electrosurgery System
Summary page 2
…) 225312 Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, Arthro…
Arthrocare Corp.1997—
*K971532Arthrocare Electrosurgery System
Summary page 2
…Predicate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Or…
Arthrocare Corp.1997—
*K973478Arthrocare Sinus Electrosurgery System
Summary page 2
…ate device(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic…
Arthrocare Corp.1998—
*K974022VAPR
Summary page 2
…e(s): K000036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electros…
Mitek Products1998—
*K981870Visage Cosmetic Surgery System
Summary page 2
…00036 Device description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electrosurgery S…
Arthrocare Corp.1998—
*K992180Visage Cosmetic Surgery, Model V5000
Summary page 2
…evice description: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electrosurgery System A…
Arthrocare Corp.2000—
*K992406Vapr 2.3MM End Effect Electrode for Use with Vapr System
Summary page 2
…scription: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electrosurgery System ArthroCar…
Mitek Products1999—
*K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…
Summary page 2
…n: K000044 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electrosurgery System ArthroCare, Arthr…
Arthrocare Corp.1999—
*K992972Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare…
Summary page 2
…44 K000074 K000228 K000511 K000936 K001302 K001936 K943450 K955531 K960169 K962445 K963123 K963783 K964849 K971532 K973478 K974022 K981870 K992180 K992406 K992581 K992972 ArthroCare, ArthroCare® ENTec™ ReFlex™ Wand ArthroCare, ArthroCare® Orthopedic Electrosurgery System ArthroCare, ArthroCare® El…
Arthrocare Corp.1999—

Also cleared against K000036: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • 1 of the 33 ancestors has a recall of any class.
  • Of its descendants, K052692 (Suretek Medical, 2006) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K000036.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Reprocessed soft tissue ablators are to be used in patients requiring arthroscopic surgery of the knee, shoulder, ankle, hip, wrist and elbow to resect, ablate and excise soft tissue.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K000036

2 other devices cite the same predicate.

  • K032838Celon Ent SystemCelon AG Medical Instruments · 2003
  • K014290Entec Plasma WandsArthrocare Corp. · 2002

More from Alliance Medical Corp.

36 FDA decisions under this applicant name. See the company

  • K060648Reprocessed Phacoemulsification TipsAlliance Medical Corp. · 2007
  • K061045Reprocessed Electrophysiology CathetersAlliance Medical Corp. · 2006
  • K060049Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K060091Alliance Medical Corporation Reprocessed Compression SleevesAlliance Medical Corp. · 2006
  • K053316Reprocessed Compression SleevesAlliance Medical Corp. · 2006

Recent decisions in GEI

The GEI category page

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K012631 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012631: Reprocessed Soft Tissue Ablators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012631

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026