Cleared Traditional

K891401 - HEMOSTATIC FORCEPS BRUNS.

K891401 is the FDA 510(k) clearance for HEMOSTATIC FORCEPS BRUNS. by Zinnanti Surgical Instruments, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K891401 · Zinnanti Surgical Instruments, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
23d
Days
Class 1
Risk

K891401 is an FDA 510(k) clearance for the HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT. 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 6, 1989 after a review of 23 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

Submission Details

510(k) Number K891401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date April 06, 1989
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 53
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K891401.
PALPATION PROBE
K911159 · Northgate Technologies, Inc. · Mar 1991
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989
PILLING HEMOSTATIC CLIP APPLIER FORCEPS
K854916 · Pilling Co. · Jan 1986
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · The Huxley Instrument Corp. · Jul 1985
IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS
K852717 · The Huxley Instrument Corp. · Jul 1985
CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420
K852730 · The Huxley Instrument Corp. · Jul 1985