Cleared Traditional

ADD-A-CATH

K884061 · Femcare , Ltd. · Gastroenterology & Urology
Oct 1988
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K884061 is an FDA 510(k) clearance for the ADD-A-CATH, a Catheter, Suprapubic (and Accessories) (Class II — Special Controls, product code KOB), submitted by Femcare , Ltd. (Nottingham, England, GB). The FDA issued a Cleared decision on October 25, 1988, 29 days after receiving the submission on September 26, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5090.

Submission Details

510(k) Number K884061 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1988
Decision Date October 25, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KOB — Catheter, Suprapubic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5090

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