Cleared Traditional

K841387 - WESTON RECTAL SNARE
(FDA 510(k) Clearance)

K841387 · Imm Enterprises , Ltd. · Gastroenterology & Urology
May 1984
Decision
43d
Days
Class 1
Risk

K841387 is an FDA 510(k) clearance for the WESTON RECTAL SNARE. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA).

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 43 days after receiving the submission on March 27, 1984.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K841387 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1984
Decision Date May 09, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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