Cleared Traditional

SKIN CLOSURE (K840945) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K840945 · Gainor Medical · General & Plastic Surgery device
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Oct 1984
Decision
240d
Days
Class 1
Risk

K840945 is an FDA 510(k) clearance for the SKIN CLOSURE. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Gainor Medical. The FDA issued a Cleared decision on October 31, 1984 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gainor Medical devices

Submission Details

510(k) Number K840945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1984
Decision Date October 31, 1984
Days to Decision 240 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
125d slower than avg
Panel avg: 115d · This submission: 240d
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 34
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K840945.
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