Cleared Traditional

K893995 - DERMACARE TIE HOLDER

K893995 is an FDA 510(k) clearance for DERMACARE TIE HOLDER, manufactured by Dermacare. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K893995 · Dermacare · General & Plastic Surgery device
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Aug 1989
Decision
67d
Days
Class 1
Risk

K893995 is an FDA 510(k) clearance for the DERMACARE TIE HOLDER. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Dermacare (Louisville, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - 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 Dermacare devices

FDA 510(k) Submission Details - K893995

510(k) Number K893995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date August 11, 1989
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

KGS Device Classification - Class 1, General Controls

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
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 - KGS Retention Device, Suture

All 14
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K893995.
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
ACUFEX FIXATION BUTTON
K896310 · Acufex Microsurgical, Inc. · Nov 1989
ACUFEX FIXATION BUTTON
K884565 · Acufex Microsurgical, Inc. · Feb 1989
HEWSON A.C.L. GUIDE SET
K872608 · Concept, Inc. · Sep 1987
BIOMER * PLEDGET SUTURE BUTTRESS
K832138 · Ethicon, Inc. · May 1984