Cleared Traditional

K883299 - SUTURE RETENTION DEVICE

K883299 is an FDA 510(k) clearance for SUTURE RETENTION DEVICE, manufactured by Edwards Orthopaedics Div., Baxter Healthcare Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K883299 · Edwards Orthopaedics Div., Baxter Healthcare Corp. · General & Plastic Surgery device
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Aug 1988
Decision
19d
Days
Class 1
Risk

K883299 is an FDA 510(k) clearance for the SUTURE RETENTION DEVICE. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Edwards Orthopaedics Div., Baxter Healthcare Corp. (Santa Ana, US). The FDA issued a Cleared decision on August 23, 1988 after a review of 19 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 Edwards Orthopaedics Div., Baxter Healthcare Corp. devices

FDA 510(k) Submission Details - K883299

510(k) Number K883299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1988
Decision Date August 23, 1988
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 13
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K883299.
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
CRUCIATE LIGAMENT BUTTON
K813581 · Biomet, Inc. · Mar 1982