Cleared Traditional

AUTO SUTURE PITUITARY SPINAL RONGEUR

K943115 · United States Surgical, A Division of Tyco Healthc · Neurology
Jul 1994
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K943115 is an FDA 510(k) clearance for the AUTO SUTURE PITUITARY SPINAL RONGEUR, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 25, 1994, 28 days after receiving the submission on June 27, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K943115 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1994
Decision Date July 25, 1994
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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