510(k) Report

510(k) · Cleared

Cleared

Gomco Circumcision Clamp

K894201510(k) TraditionalCleared Aug 11, 198956-day reviewClass II21 CFR 884.4530

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

Zinnanti Surgical Instruments, Inc. · HFX Clamp, Circumcision

Cleared on Aug 11, 1989 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 11, 1989
Review
56 days
Class
Class II
Product code
HFX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK894201 Gomco Circumcision ClampZinnanti Surgical Instruments, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK063429 GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894201Gomco Circumcision ClampZinnanti Surgical Instruments, Inc.1989—
+1K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K894201, 1989–2007Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HFX? 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 HFX device

  1. #1 K251687 Konig Bell Circumcision Clampscore 11.2 · 2 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?

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

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc.20070

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?

  • Of its descendants, K063429 (Generic Medical Device, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HFX devices

HFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFX

1in 2023

2007: 22010: 12012: 22013: 12015: 22022: 12023: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFX

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

Recalls per year · HFX

1in 2024

2011: 32014: 22016: 12019: 22024: 1
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · HFX

122in 2025

2007: 172008: 62009: 202010: 212011: 122012: 142013: 162014: 202015: 212016: 1472017: 252018: 132019: 112020: 222021: 52022: 32023: 332024: 1212025: 122
2007high 147 (2016) · low 3 (2022)2025

MAUDE reports naming product code HFX, 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
20072—017
20080—06
20090—020
20101—021
20110—312
20122—014
20131—016
20140—220
20152—021
20160—1147
20170—025
20180—013
20190—211
20200—022
20210—05
20221—03
20231—033
20240—1121
20250—0122
20261—0—

More from Zinnanti Surgical Instruments, Inc.

76 FDA decisions under this applicant name. See the company

  • K925501Nylon Coated SpeculaZinnanti Surgical Instruments, Inc. · 1997
  • K941458Uterine Manipulator/Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
  • K941457Uterine Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
  • K925560Zsi Loop, Zsi Ball & Zsi Needle ElectrodesZinnanti Surgical Instruments, Inc. · 1994
  • K925957Scissors for Laparoscopic Surgery OB/Gyn UseZinnanti Surgical Instruments, Inc. · 1994

Recent decisions in HFX

The HFX category page

  • K251687Konig Bell Circumcision ClampMedline Industries, LP · 2026
  • K221356Wee BellWee Medical · 2023
  • K212911Konig Mogen ClampMedline Industries, Inc. · 2022
  • K151095Circumplast Circumcision DeviceNovadien Healthcare · 2015
  • K142163Male Circumcision Kits:RapideclampMedicfit Technology Sdn Bhd · 2015

https://510kreport.com/device/K894201 · printed Nov 6, 2026

Cite this page

510(k) Report. “K894201: Gomco Circumcision Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894201

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