Cleared Traditional

MARLOW ANAL SPECULUM

K891352 · Simpson/Basye, Inc. · Gastroenterology & Urology
Jun 1989
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K891352 is an FDA 510(k) clearance for the MARLOW ANAL SPECULUM, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on June 23, 1989, 105 days after receiving the submission on March 10, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K891352 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1989
Decision Date June 23, 1989
Days to Decision 105 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