Cleared Traditional

K904136 - SUTURE TENSION ADJUSTMENT REEL

K904136 is an FDA 510(k) clearance for SUTURE TENSION ADJUSTMENT REEL, manufactured by Surgical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K904136 · Surgical Systems, Inc. · General & Plastic Surgery device
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Oct 1990
Decision
26d
Days
Class 1
Risk

K904136 is an FDA 510(k) clearance for the SUTURE TENSION ADJUSTMENT REEL. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Surgical Systems, Inc. (Miami, US). The FDA issued a Cleared decision on October 2, 1990 after a review of 26 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 Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K904136

510(k) Number K904136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date October 02, 1990
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 K904136.
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
MITEK CONE WASHER
K930675 · Mitek Surgical Products, Inc. · Nov 1993
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