Cleared Traditional

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

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

K904435 is an FDA 510(k) clearance for the VENTROFIL TENSION RELIEF SUTURE SET, a Retention Device, Suture (Class I — General Controls, product code KGS), submitted by Aesculap, Inc. (Burlingame, US). The FDA issued a Cleared decision on August 29, 1991, 335 days after receiving the submission on September 28, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4930.

Submission Details

510(k) Number K904435 FDA.gov
FDA Decision Cleared 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 —

Device Classification

Product Code KGS — Retention Device, Suture
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4930