Cleared Traditional

SPYROFLEX WOUND CLOSURES (K921775) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K921775 · Polymint Industrial Co. , Ltd. · General & Plastic Surgery device
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May 1992
Decision
39d
Days
Class 1
Risk

K921775 is an FDA 510(k) clearance for the SPYROFLEX WOUND CLOSURES. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Polymint Industrial Co. , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on May 19, 1992 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Polymint Industrial Co. , Ltd. devices

Submission Details

510(k) Number K921775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1992
Decision Date May 19, 1992
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - FPX Strip, Adhesive, Closure, Skin

All 9
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K921775.
DERMA STRIP-TM SKIN CLOSURES
K833083 · Howmedica Corp. · Dec 1983
BAND AID* ADHESIVE BANDAGES
K782003 · Johnson & Johnson Professionals, Inc. · Jan 1979
PAPER TAPE, HYPO ALLERGENIC
K781952 · Johnson & Johnson Professionals, Inc. · Dec 1978
SUTURELESS SKIN CLOSURE
K780565 · Abbott Laboratories · Jul 1978
CLOTH ADHESIVE TAPE
K772020 · Johnson & Johnson Professionals, Inc. · Nov 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · Johnson & Johnson Professionals, Inc. · Jun 1977