Cleared Traditional

MITEK ABSORBABLE ANCHOR

K941599 · Mitek Surgical Products, Inc. · Gastroenterology & Urology
Oct 1995
Decision
571d
Days
Class 2
Risk

About This 510(k) Submission

K941599 is an FDA 510(k) clearance for the MITEK ABSORBABLE ANCHOR, a Strip, Dialysate Ph Indicator (Class II — Special Controls, product code MNV), submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on October 24, 1995, 571 days after receiving the submission on April 1, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K941599 FDA.gov
FDA Decision Cleared SN
Date Received April 01, 1994
Decision Date October 24, 1995
Days to Decision 571 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code MNV — Strip, Dialysate Ph Indicator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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