Cleared Traditional

K926535 - GOMCO CIRCUMCISION CLAMP

K926535 is an FDA 510(k) clearance for GOMCO CIRCUMCISION CLAMP, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K926535 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
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Feb 1994
Decision
422d
Days
Class 2
Risk

K926535 is an FDA 510(k) clearance for the GOMCO CIRCUMCISION CLAMP. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K926535

510(k) Number K926535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date February 25, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 160d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFX Clamp, Circumcision

All 7
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K926535.
Konig Mogen Clamp
K212911 · Medline Industries, Inc. · Nov 2022
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · Trinity Laboratories, Inc. · Dec 1997
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994
GOMCO CIRCUMCISION CLAMP
K894201 · Zinnanti Surgical Instruments, Inc. · Aug 1989
BAXTER DISPOSABLE CIRCUMCISION TRAY
K884290 · Baxter Healthcare Corp · Dec 1988