Cleared Traditional

K832138 - BIOMER * PLEDGET SUTURE BUTTRESS

K832138 is the FDA 510(k) clearance for BIOMER * PLEDGET SUTURE BUTTRESS by Ethicon, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K832138 · Ethicon, Inc. · General & Plastic Surgery device
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May 1984
Decision
327d
Days
Class 1
Risk

K832138 is an FDA 510(k) clearance for the BIOMER * PLEDGET SUTURE BUTTRESS. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ethicon, Inc. devices

Submission Details

510(k) Number K832138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1983
Decision Date May 23, 1984
Days to Decision 327 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
212d slower than avg
Panel avg: 115d · This submission: 327d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 11
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K832138.
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
CRUCIATE LIGAMENT BUTTON
K813581 · Biomet, Inc. · Mar 1982
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819 · Ethicon, Inc. · Nov 1981
HEWSON LIGAMENT BUTTON
K792004 · Richard'S Medical Equip., Inc. · Nov 1979