510(k) Report

510(k) · Cleared

Cleared

Modification to EN-Bloc Biopsy System

K052246510(k) TraditionalCleared Aug 22, 20055-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

Neothermia Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 22, 2005 as substantially equivalent to K003190 (Neothermia Corp., 2001) and 5 other predicates after a 5-day review. Its family tree reaches back 4 generations to 1987.

Decided
Aug 22, 2005
Review
5 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K871390 (1987). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 2 other ancestorsK871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 1987K963825 · Auto Suture* Abbi* System · United States Surgical, A Division of Tyco Healthc · 1996K983296 · Auto Suture Abbi System · United States Surgical, A Division of Tyco Healthc · 1999K020031 · EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 · Neothermia Corp. · 200219851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors K020031 · EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 · Neothermia Corp. · 2002K983296 · Auto Suture Abbi System · United States Surgical, A Division of Tyco Healthc · 1999K963825 · Auto Suture* Abbi* System · United States Surgical, A Division of Tyco Healthc · 1996K871390 · Bard Biopty Biopsy System · C.R. Bard, Inc. · 19870
  1. Root · 4 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
  2. 3 generations backK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
  3. 2 generations backK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
  4. 1 generation backK020031 EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002…Neothermia Corp. · 2002
  5. This deviceK052246 Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K871390Bard Biopty Biopsy SystemC.R. Bard, Inc.1987—
−3K963825Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc1996—
−2K983296Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc1999—
−1K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006…Neothermia Corp.2002—
0 (this device)K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200210
200310
200410
200510
FIG. 1 — Lineage of K052246, 1987–2005Source: 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? (6)

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
*K003190EN Bloc Biopsy System
Summary page 1
…, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy Sy…
Neothermia Corp.200111
*K021577Modification to EN-Bloc Biopsy System
Summary page 1
…16 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy System is i…
Neothermia Corp.2002—
*K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
Summary page 1
…Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy System is indicated t…
Neothermia Corp.2002—
*K042170EN-Bloc Biopsy System…
Summary page 1
…assachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy System is indicated to provide…
Neothermia Corporation2004—
*K050737Neothermia EN-Bloc Biopsy System
Summary page 1
…tts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy System is indicated to provide tissue s…
Neothermia Corporation2005—
*K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System
Summary page 1
…: (508) 655-6239 Predicate Devices Neothermia Corp.'s en-bloc Biopsy System (K003190, K021577, K02003 1, K042170, K050737) and the Ethicon Endo-Surgery Mammotome 510(k) K030472. Intended Use The en-bloc Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.…
Ethicon Endo-Surgery, Inc.2003—

Also cleared against K003190: 3 other devices →

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 18 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K003190.

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?

The en-bloc Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be…

Read the full statement (205 words)

The en-bloc Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.

The en-bloc Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the en-bloc Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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.

Also cleared against K003190

3 other devices cite the same predicate.

  • K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc. · 20021 recall
  • K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
  • K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002

More from Neothermia Corporation

3 FDA decisions under this applicant name. See the company

  • K050737Neothermia EN-Bloc Biopsy SystemNeothermia Corporation · 2005
  • K042170EN-Bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120Neothermia Corporation · 2004

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https://510kreport.com/device/K052246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052246: Modification to EN-Bloc Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052246

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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