Cleared Traditional

MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) (K884181) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K884181 · Sales & Marketing Assoc. · General & Plastic Surgery device
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Nov 1988
Decision
38d
Days
Class 1
Risk

K884181 is an FDA 510(k) clearance for the MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS). Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Sales & Marketing Assoc. (Berkley Heights, US). The FDA issued a Cleared decision on November 10, 1988 after a review of 38 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 Sales & Marketing Assoc. devices

Submission Details

510(k) Number K884181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date November 10, 1988
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 8
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K884181.
NORSEN DEBRIDER
K800647 · Medline Industries, Inc. · Apr 1980
CASTROVIEJO VASCULAR NEEDLEHOLDER 538425
K792309 · Edward Weck, Inc. · Nov 1979
VASCULAR FORCEPS & CLAMPS
K791987 · Edward Weck, Inc. · Oct 1979
CARROLL TENDON RETRIEVER
K772393 · Edward Weck, Inc. · May 1978
LONG JEWELERS FORCEPS
K772383 · Edward Weck, Inc. · Mar 1978
SUTURE TISSUE APPROXIMATING FORCEP
K771515 · United States Surgical, A Division of Tyco Healthc · Sep 1977