Cleared Traditional

K946360 - MODULAR BIOPSY FORCEP

K946360 is an FDA 510(k) clearance for MODULAR BIOPSY FORCEP, manufactured by Cox Medical Ent., Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K946360 · Cox Medical Ent., Inc. · Gastroenterology & Urology device
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Mar 1995
Decision
66d
Days
Class 1
Risk

K946360 is an FDA 510(k) clearance for the MODULAR BIOPSY FORCEP. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Cox Medical Ent., Inc. (Ventura, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Cox Medical Ent., Inc. devices

FDA 510(k) Submission Details - K946360

510(k) Number K946360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date March 06, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

FCL Device Classification - Class 1, General Controls

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FCL Forceps, Biopsy, Non-electric

All 12
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K946360.
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