Cleared Traditional

VESITEC SUTURE PASSER

K931181 · Vesitec Medical, Inc. · Gastroenterology & Urology
May 1993
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K931181 is an FDA 510(k) clearance for the VESITEC SUTURE PASSER, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Vesitec Medical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 12, 1993, 64 days after receiving the submission on March 9, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K931181 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1993
Decision Date May 12, 1993
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KOA — Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.4730