Cleared Traditional

VENTROFIL TENSION RELIEF SUTURE SET (K904435) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K904435 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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.