Cleared Traditional

K872608 - HEWSON A.C.L. GUIDE SET

K872608 is an FDA 510(k) clearance for HEWSON A.C.L. GUIDE SET, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K872608 · Concept, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
72d
Days
Class 1
Risk

K872608 is an FDA 510(k) clearance for the HEWSON A.C.L. GUIDE SET. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 72 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 Concept, Inc. devices

FDA 510(k) Submission Details - K872608

510(k) Number K872608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date September 16, 1987
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 12
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K872608.
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
BIOMER * PLEDGET SUTURE BUTTRESS
K832138 · Ethicon, Inc. · May 1984
CRUCIATE LIGAMENT BUTTON
K813581 · Biomet, Inc. · Mar 1982
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819 · Ethicon, Inc. · Nov 1981