Cleared Traditional

K953962 - FORCEPS

K953962 is an FDA 510(k) clearance for FORCEPS, manufactured by Biopsys Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K953962 · Biopsys Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
17d
Days
Class 1
Risk

K953962 is an FDA 510(k) clearance for the FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Biopsys Medical, Inc. devices

FDA 510(k) Submission Details - K953962

510(k) Number K953962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 08, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

GEN Device Classification - Class 1, General Controls

Product Code GEN Forceps, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEN Forceps, General & Plastic Surgery

All 69
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K953962.
PALPATION PROBE
K911159 · Northgate Technologies, Inc. · Mar 1991
GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
K900948 · Solos Endoscopy, Inc. · Apr 1990
GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP
K900951 · Solos Endoscopy, Inc. · Apr 1990
GS-1200 GRASPING/EXTRACTING FORCEP, 10MM
K900952 · Solos Endoscopy, Inc. · Apr 1990
GS-1500 CLAW FORCEP, 10MM
K900960 · Solos Endoscopy, Inc. · Apr 1990
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989