Cleared Traditional

SNAP-N-PEEL INTRODUCERS

K981611 · Circon Corp. · Gastroenterology & Urology
Jul 1998
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K981611 is an FDA 510(k) clearance for the SNAP-N-PEEL INTRODUCERS, a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY), submitted by Circon Corp. (Santa Barbara, US). The FDA issued a Cleared decision on July 30, 1998, 85 days after receiving the submission on May 6, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K981611 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1998
Decision Date July 30, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNY — Accessories, Catheter, G-u
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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