Cleared Traditional

RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU

K892542 · Zinnanti Surgical Instruments, Inc. · Gastroenterology & Urology
May 1989
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K892542 is an FDA 510(k) clearance for the RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU, a Clamp, Non-electrical (Class I — General Controls, product code FFN), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 9, 1989, 28 days after receiving the submission on April 11, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K892542 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 09, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FFN — Clamp, Non-electrical
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.4730