510(k) Report

510(k) · Cleared

Cleared

Fas-Clean Electrosurgical Coated Active Blade

K073616510(k) TraditionalCleared Jul 23, 2008210-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

Electromedics Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 23, 2008 as substantially equivalent to K962935 (Unimed Surgical Products, Inc., 1996) and 3 other predicates after a 210-day review. Its family tree reaches back 2 generations to 2004. 25 later devices descend from it.

Decided
Jul 23, 2008
Review
210 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K033003 (2004). 5 ancestors in all, the oldest K943055 (1994). 25 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1994: 1 other ancestor2008: 1 descendant cleared2012: 1 descendant cleared2014: 4 descendants cleared2010: 3 descendants cleared2016: 2 descendants cleared2015: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2019: 1 descendant cleared2022: 3 descendants cleared2026: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK033003 · Suction Coagulator · Modern Medical Equipment Mfg., Ltd. · 2004 · recalledK052104 · Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction · Conmed Corporation · 2005 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K052104 · Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction · Conmed Corporation · 2005 · recalledK033003 · Suction Coagulator · Modern Medical Equipment Mfg., Ltd. · 2004 · recalled0+5
  1. Root · 2 generations backK033003 Suction CoagulatorModern Medical Equipment Mfg., Ltd. · 2004 · Recalled
  2. 1 generation backK052104 Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183…Conmed Corporation · 2005 · Recalled
  3. This deviceK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
  4. Descendant · cites it directly · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  6. Descendant · 2 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
  7. Descendant · 2 generations on · 6 of its ownK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
  8. Descendant · 3 generations on · 5 of its ownK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2008: 12010: 32012: 12014: 42015: 22016: 22017: 12018: 12019: 12020: 32022: 32024: 12025: 12026: 1
2008high 4 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 25 · See all
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · cites it directly24descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 2 generations on8descendants
  • K142410Elliquence ElectrodesElliquence, LLC · 2015 · 2 generations on7descendants
  • K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016 · 2 generations on6descendants
  • K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K033003Suction CoagulatorModern Medical Equipment Mfg., Ltd.20041
−1K052104Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184…Conmed Corporation20051
0 (this device)K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.2008—
+1K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+2K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+2K142410Elliquence ElectrodesElliquence, LLC2015—
+2K160041Cobbra RF Tissue DissectorElliquence, LLC2016—
+3K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201030
201210
201440
201520
201620
201710
201810
201910
202030
202230
202410
202510
202610
FIG. 1 — Lineage of K073616, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*K962935Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode
Summary page 1
…me: Electrosurgical cutting and coagulation device and accessories Predicate Devices: Unimed Coated Blade Electrode (K962935) Valley Lab's EDGE (K962044) ConMed's UltraClean (K052104) Megadyne's EX Clean (K943055) ELECTROMEDICS' FAS-CLEAN Electrosurgica…
Unimed Surgical Products, Inc.199613
*K962044Valleylab Coated Electrodes
Summary page 1
…rgical cutting and coagulation device and accessories Predicate Devices: Unimed Coated Blade Electrode (K962935) Valley Lab's EDGE (K962044) ConMed's UltraClean (K052104) Megadyne's EX Clean (K943055) ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is sub…
Valleylab, Inc.1996—
*K052104Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185…
Summary page 1
…device and accessories Predicate Devices: Unimed Coated Blade Electrode (K962935) Valley Lab's EDGE (K962044) ConMed's UltraClean (K052104) Megadyne's EX Clean (K943055) ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is substantially equivalent to the U…
Conmed Corporation20051
*K943055Electrosurgical Cutting and Coagulating Device and Accessories
Summary page 1
…accessories Predicate Devices: Unimed Coated Blade Electrode (K962935) Valley Lab's EDGE (K962044) ConMed's UltraClean (K052104) Megadyne's EX Clean (K943055) ELECTROMEDICS' FAS-CLEAN Electrosurgical Coated Active Blade is substantially equivalent to the Unimed Coated Blade Electrode,…
Megadyne Medical Products, Inc.19942

Also cleared against K962935: 2 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.200824

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 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • Of its descendants, K082786 (Peak Surgical, Inc., 2008) has gone furthest, with 24 descendants of its own.
  • 2 other devices also cite its predicate K962935.

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. 2008, this device’s year, is highlighted.

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?

The FAS-CLEAN Electrosurgical Coated Active Blade, a single use, sterile, monopolar, Emralon coated electrode is intended for use:

* In surgical procedures (general, neurosurgical, laparoscopic, orthopedic, and gynecologic) where monopolhr electrosurgical cutting and coagulation are normally used.

* As an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes, which are used for these indications.

Indications for use as stated in the FDA summary.

Also cleared against K962935

2 other devices cite the same predicate.

  • K132224Unimed Surgical Coated Electrosurgical ElectrodesUnimed Surgical Products, Inc. · 2013
  • K970066Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation ElectrodeUnimed Surgical Products, Inc. · 19971 recall

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • 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/K073616 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073616: Fas-Clean Electrosurgical Coated Active Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073616

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026