510(k) Report

510(k) · Cleared

Cleared

GMD Universal Circumcision Clamp, Model 200

K063429510(k) TraditionalCleared Jan 17, 200765-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

Generic Medical Device, Inc. · HFX Clamp, Circumcision

Cleared on Jan 17, 2007 as substantially equivalent to K894201 (Zinnanti Surgical Instruments, Inc., 1989) after a 65-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jan 17, 2007
Review
65 days
Class
Class II
Product code
HFX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K894201 (1989). No later device cites it as a predicate yet.

K894201 · Gomco Circumcision Clamp · Zinnanti Surgical Instruments, Inc. · 198919851990199520002005
K894201 · Gomco Circumcision Clamp · Zinnanti Surgical Instruments, Inc. · 19890
  1. Root · 1 generation backK894201 Gomco Circumcision ClampZinnanti Surgical Instruments, Inc. · 1989
  2. This deviceK063429 GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894201Gomco Circumcision ClampZinnanti Surgical Instruments, Inc.1989—
0 (this device)K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc.2007—
FIG. 1 — Lineage of K063429, 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), 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 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
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What was it cleared against? (1)

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
*K894201Gomco Circumcision Clamp
Summary page 1
…rcumcision Classification Name: Clamps, Circumcision Class II: Obstetric-gynecologic specialized manual instrument 21 CFR 884.4530, Product Code HFX. Predicate Devices: K894201 - GOMCO Circumcision Clamp Manufactured by: Zinnanti Surgical Instruments 21540-B Prairie Street Chatsworth, California 91311 5…
Zinnanti Surgical Instruments, Inc.1989—

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?

  • Its one ancestor has no recall.

How does its category compare?

All HFX devices

HFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Indications for use as stated in the FDA summary.

More from Generic Medical Device, Inc.

4 FDA decisions under this applicant name. See the company

  • K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 20092 recalls
  • K070018Universal Surgical Mesh, Model 100Generic Medical Device, Inc. · 2007

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/K063429 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063429: GMD Universal Circumcision Clamp, Model 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063429

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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