Cleared Traditional

K863930 - VISCOPASTE ZINC PASTE BANDAGE

K863930 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
54d
Days
-
Risk

K863930 is an FDA 510(k) clearance for the VISCOPASTE ZINC PASTE BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K863930

510(k) Number K863930 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1986
Decision Date December 01, 1986
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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 476
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K863930.
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
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COMPRESS AND BANDAGE, VARIOUS SIZES
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FERRIS DYNADERM PLUS
K865089 · Ferris Mfg. Corp. · Feb 1987
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · Acme United Corp. · Nov 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986