Cleared Traditional

K884108 - MACROPORE MEDICAL/SURGICAL PAPER TAPE

K884108 is an FDA 510(k) clearance for MACROPORE MEDICAL/SURGICAL PAPER TAPE, manufactured by Lectec Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K884108 · Lectec Corp. · General & Plastic Surgery device
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Nov 1988
Decision
42d
Days
Class 1
Risk

K884108 is an FDA 510(k) clearance for the MACROPORE MEDICAL/SURGICAL PAPER TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on November 10, 1988 after a review of 42 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 Lectec Corp. devices

FDA 510(k) Submission Details - K884108

510(k) Number K884108 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 29, 1988
Decision Date November 10, 1988
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 77
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K884108.
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
LEUKOPOR(TM) SURGICAL TAPE
K881509 · Beiersdorf, Inc. · Apr 1988
LIGHTPLAST(TM)
K872975 · Beiersdorf, Inc. · Aug 1987
THE GRIPPER SEAL(TM)
K870900 · Pharmacia Deltec, Inc. · Mar 1987