Cleared Traditional

SHUR-GRIP

K912834 · Inman Medical Corp. · General & Plastic Surgery
Jul 1991
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K912834 is an FDA 510(k) clearance for the SHUR-GRIP, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Inman Medical Corp. (Arlington, US). The FDA issued a Cleared decision on July 26, 1991, 30 days after receiving the submission on June 26, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K912834 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1991
Decision Date July 26, 1991
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KDC — Instrument, Surgical, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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