Cleared Traditional

K873978 - DISPOSABLE BIPOLAR FORCEPS

K873978 is an FDA 510(k) clearance for DISPOSABLE BIPOLAR FORCEPS, manufactured by E.M. Adams. The device is a Class 1 General & Plastic Surgery device with product code GEN cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K873978 · E.M. Adams · General & Plastic Surgery device
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Nov 1987
Decision
54d
Days
Class 1
Risk

K873978 is an FDA 510(k) clearance for the DISPOSABLE BIPOLAR FORCEPS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by E.M. Adams (Medfield, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 54 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 E.M. Adams devices

FDA 510(k) Submission Details - K873978

510(k) Number K873978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1987
Decision Date November 23, 1987
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 63
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K873978.
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
GRASPING FORCEP, 1.7MM
K871926 · Arthropedics, Inc. · Jun 1987
CUP BIOPSY FORCEP, 1.7MM
K871927 · Arthropedics, Inc. · Jun 1987
PILLING HEMOSTATIC CLIP APPLIER FORCEPS
K854916 · Pilling Co. · Jan 1986