Cleared Traditional

K935491 - CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)

K935491 is an FDA 510(k) clearance for CENTURION MOGEN CLAMP/CIRCUMCISION (STE..., manufactured by Tri-State Hospital Supply Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K935491 · Tri-State Hospital Supply Corp. · Obstetrics & Gynecology device
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Feb 1994
Decision
94d
Days
Class 2
Risk

K935491 is an FDA 510(k) clearance for the CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER). Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tri-State Hospital Supply Corp. devices

FDA 510(k) Submission Details - K935491

510(k) Number K935491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date February 17, 1994
Days to Decision 94 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
66d faster than avg
Panel avg: 160d · This submission: 94d
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 11
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K935491.
CIRCUMCISION TRAY
K935697 · Cush Medical Products · May 1994
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994
GOMCO CIRCUMCISION CLAMP
K926535 · 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