Cleared Traditional

K891896 - TISSUE FORCEPS, VARIOUS TYPES

K891896 is an FDA 510(k) clearance for TISSUE FORCEPS, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K891896 · Zinnanti Surgical Instruments, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
19d
Days
Class 1
Risk

K891896 is an FDA 510(k) clearance for the TISSUE FORCEPS, VARIOUS TYPES. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 19 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 Zinnanti Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K891896

510(k) Number K891896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date April 12, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 68
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K891896.
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
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
K891401 · Zinnanti Surgical Instruments, Inc. · Apr 1989
DISPOSABLE BIPOLAR FORCEPS
K873978 · E.M. Adams · Nov 1987
VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
K872271 · New England Surgical Instrument Corp. · Jun 1987