Cleared Traditional

K894201 - GOMCO CIRCUMCISION CLAMP

K894201 is an FDA 510(k) clearance for GOMCO CIRCUMCISION CLAMP, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K894201 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Aug 1989
Decision
56d
Days
Class 2
Risk

K894201 is an FDA 510(k) clearance for the GOMCO CIRCUMCISION CLAMP. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zinnanti Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K894201

510(k) Number K894201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date August 11, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
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 17
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K894201.
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994
GOMCO CIRCUMCISION CLAMP
K926535 · Thomasville Medical Assoc. · Feb 1994
CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
K935491 · Tri-State Hospital Supply Corp. · Feb 1994
BAXTER DISPOSABLE CIRCUMCISION TRAY
K884290 · Baxter Healthcare Corp · Dec 1988