510(k) Report

510(k) · Cleared

Cleared

Bipolar Snare

K950776510(k) TraditionalCleared Apr 18, 199556-day reviewClass I21 CFR 878.4800

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

Cook Urological, Inc. · GAE Snare, Surgical

Cleared on Apr 18, 1995 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 18, 1995
Review
56 days
Class
Class I
Product code
GAE
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K950776Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All GAE devices

GAE Snare, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAE

FDA has decided no GAE device since 2007.

Median 510(k) review, days · GAE

Too few GAE 510(k)s in any year since 2007 to give a median.

Recalls per year · GAE

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAE

9in 2025

2007: 22008: 202009: 62010: 102011: 12012: 22013: 52014: 32015: 102016: 92017: 82018: 42019: 52020: 42021: 12022: 12023: 122024: 132025: 9
2007high 20 (2008) · low 1 (2011)2025

MAUDE reports naming product code GAE, 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
20070—02
20080—220
20090—06
20100—010
20110—01
20120—02
20130—05
20140—03
20150—010
20160—09
20170—08
20180—04
20190—05
20200—04
20210—01
20220—01
20230—012
20240—013
20250—09
20260—0—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in GAE

The GAE category page

  • K926036Acufex Suture RetrieverAcufex Microsurgical, Inc. · 1993
  • K903174Advance Suture Absorbable Gut SutureAdvance Suture, Inc. · 1991
  • K881224Acufex Suture Retriever, Sterile DisposableAcufex Microsurgical, Inc. · 1988

https://510kreport.com/device/K950776 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950776: Bipolar Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950776

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026