510(k) Report

510(k) · Cleared

Cleared

Flexible Loop Electrosurgical Electrode

K070275510(k) TraditionalCleared Mar 9, 200739-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

Rubicor Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 9, 2007 as substantially equivalent to K052506 (Rubicor Medical, Inc., 2005) and 3 other predicates after a 39-day review. Its family tree reaches back 5 generations to 1993.

Decided
Mar 9, 2007
Review
39 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K922123 (1993). 17 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1999: 1 other ancestorK922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 1993K020047 · Rubicor Breast Biopsy Device · Rubicor Medical, Inc. · 2002 · recalled×2: 2 generations cleared close together, K023601 (2002), K030049 (2003) K052506 · Rubicor Encapsule Breast Biopsy Device, Model 31108 · Rubicor Medical, Inc. · 2005 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors4 generations back: 2 other ancestors K052506 · Rubicor Encapsule Breast Biopsy Device, Model 31108 · Rubicor Medical, Inc. · 2005 · recalledK030049 · Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2003 · recalledK023601 · Rubicor Encapsule Breast Biopsy Device, Model 30086 · Rubicor Medical, Inc. · 2002 · recalledK020047 · Rubicor Breast Biopsy Device · Rubicor Medical, Inc. · 2002 · recalledK922123 · Auto Suture Disposable Endoscopic Specimen Pouch · United States Surgical, A Division of Tyco Healthc · 1993−50
  1. Root · 5 generations backK922123 Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 4 generations backK020047 Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 2002 · Recalled
  3. 3 generations backK023601 Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2002 · Recalled
  4. 2 generations backK030049 Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 2003 · Recalled
  5. 1 generation backK052506 Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 2005 · Recalled
  6. This deviceK070275 Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K922123Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc1993—
−4K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.20021
−3K023601Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20021
−2K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc.20031
−1K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc.20051
0 (this device)K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
199310
199410
199510
199710
199910
200020
200120
200210
FIG. 1 — Lineage of K070275, 1993–2007Source: 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? (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
*K052506Rubicor Encapsule Breast Biopsy Device, Model 31108
Summary page 1
…nt Device: The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor EnCapsule~ Breast Biopsy Device (K052506), SenoRx Shape Select Scalpel (KO 12799), Wallach LOOP Electrodes (K02071 1), and Megadyne Electrosurgical Electrode (K97…
Rubicor Medical, Inc.20051
*K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc.2001—
*K020711Wallach Loop Electrode
Summary page 1
…intended use and/or method of operation to the Rubicor EnCapsule~ Breast Biopsy Device (K052506), SenoRx Shape Select Scalpel (KO 12799), Wallach LOOP Electrodes (K02071 1), and Megadyne Electrosurgical Electrode (K973 346). Intended Use: The Rubicor Flexible Loop Electrosurgical Electrode is in…
Wallach Surgical Devices, Inc.20021
*K973346Uncoated Electrosurgical Electrode
Summary page 1
…or EnCapsule~ Breast Biopsy Device (K052506), SenoRx Shape Select Scalpel (KO 12799), Wallach LOOP Electrodes (K02071 1), and Megadyne Electrosurgical Electrode (K973 346). Intended Use: The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during…
Megadyne Medical Products, Inc.1997—

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 6 of the 17 ancestors have a recall of any class.

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. 2007, 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 Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue. The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast…

Read the full statement (146 words)

The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.

The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

More from Rubicor Medical, Inc.

8 FDA decisions under this applicant name. See the company

  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
  • K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
  • K052506Rubicor Encapsule Breast Biopsy Device, Model 31108Rubicor Medical, Inc. · 20051 recall
  • K032584Rubicor Encapsule Breast Biopsy Device, Model 30629Rubicor Medical, Inc. · 20031 recall
  • K030049Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086Rubicor Medical, Inc. · 20031 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/K070275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070275: Flexible Loop Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070275

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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