Cleared Traditional

K780565 - SUTURELESS SKIN CLOSURE

K780565 is an FDA 510(k) clearance for SUTURELESS SKIN CLOSURE, manufactured by Abbott Laboratories. The device is a Class 1 General & Plastic Surgery device with product code FPX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K780565 · Abbott Laboratories · General & Plastic Surgery device
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Jul 1978
Decision
92d
Days
Class 1
Risk

K780565 is an FDA 510(k) clearance for the SUTURELESS SKIN CLOSURE. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 7, 1978 after a review of 92 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K780565

510(k) Number K780565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1978
Decision Date July 07, 1978
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

FPX Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K780565.
HANSAPOR STERILE
K792360 · Beiersdorf, Inc. · Dec 1979
BAND AID* ADHESIVE BANDAGES
K782003 · Johnson & Johnson Professionals, Inc. · Jan 1979
PAPER TAPE, HYPO ALLERGENIC
K781952 · Johnson & Johnson Professionals, Inc. · Dec 1978
CLOTH ADHESIVE TAPE
K772020 · Johnson & Johnson Professionals, Inc. · Nov 1977
POLYURETHANE PROD. FOR I.V. NEEDLES
K771125 · Devon Industries, Inc. · Aug 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · Johnson & Johnson Professionals, Inc. · Jun 1977