Cleared Traditional

K904435 - VENTROFIL TENSION RELIEF SUTURE SET

K904435 is the FDA 510(k) clearance for VENTROFIL TENSION RELIEF SUTURE SET by Aesculap, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K904435 · Aesculap, Inc. · General & Plastic Surgery device
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Aug 1991
Decision
335d
Days
Class 1
Risk

K904435 is an FDA 510(k) clearance for the VENTROFIL TENSION RELIEF SUTURE SET. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Aesculap, Inc. (Burlingame, US). The FDA issued a Cleared decision on August 29, 1991 after a review of 335 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 Aesculap, Inc. devices

Submission Details

510(k) Number K904435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date August 29, 1991
Days to Decision 335 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
220d slower than avg
Panel avg: 115d · This submission: 335d
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 K904435.
RBM
K020480 · Smith & Nephew, Inc. · Mar 2002
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
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