Cleared Traditional

K883983 - SANIFIX

K883983 is an FDA 510(k) clearance for SANIFIX, manufactured by Iberhospitex, S.A.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K883983 · Iberhospitex, S.A. · General & Plastic Surgery device
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Dec 1988
Decision
84d
Days
Class 1
Risk

K883983 is an FDA 510(k) clearance for the SANIFIX. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Iberhospitex, S.A. (Barcelona, Spain, ES). The FDA issued a Cleared decision on December 13, 1988 after a review of 84 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 Iberhospitex, S.A. devices

FDA 510(k) Submission Details - K883983

510(k) Number K883983 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 20, 1988
Decision Date December 13, 1988
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K883983.
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
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 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