Cleared Traditional

K875319 - NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS

K875319 is an FDA 510(k) clearance for NSN #6515-00-690-3209 DEBAKEY TISSUE FO..., manufactured by I-Tech Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K875319 · I-Tech Industries, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
24d
Days
Class 1
Risk

K875319 is an FDA 510(k) clearance for the NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by I-Tech Industries, Inc. (Addison, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 24 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 I-Tech Industries, Inc. devices

FDA 510(k) Submission Details - K875319

510(k) Number K875319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date January 22, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 K875319.
GS-1500 CLAW FORCEP, 10MM
K900960 · Solos Endoscopy, Inc. · Apr 1990
TISSUE FORCEPS, VARIOUS TYPES
K891896 · Zinnanti Surgical Instruments, Inc. · Apr 1989
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
GRASPING FORCEP, 1.7MM
K871926 · Arthropedics, Inc. · Jun 1987