Cleared Traditional

K883660 - DERMASTRIP

K883660 is an FDA 510(k) clearance for DERMASTRIP, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
166d
Days
Class 1
Risk

K883660 is an FDA 510(k) clearance for the DERMASTRIP. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 8, 1989 after a review of 166 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K883660

510(k) Number K883660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date February 08, 1989
Days to Decision 166 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
51d slower than avg
Panel avg: 115d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
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 - KGX Tape And Bandage, Adhesive

All 89
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K883660.
COMFEEL TRANSPARENT DRESSING
K894916 · Coloplast A/S · Sep 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · Convatec, A Division of E.R. Squibb & Sons · Sep 1989
PRIMAPORE I.V.
K893900 · Smith & Nephew United, Inc. · Aug 1989
MACROPORE MEDICAL/SURGICAL PAPER TAPE
K884108 · Lectec Corp. · Nov 1988
LEUKOPOR(TM) SURGICAL TAPE
K881509 · Beiersdorf, Inc. · Apr 1988
LIGHTPLAST(TM)
K872975 · Beiersdorf, Inc. · Aug 1987