Cleared Traditional

GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE

K914588 · Grieshaber & Co. · General & Plastic Surgery
Jun 1992
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K914588 is an FDA 510(k) clearance for the GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Grieshaber & Co. (Langhorne, US). The FDA issued a Cleared decision on June 11, 1992, 239 days after receiving the submission on October 16, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K914588 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1991
Decision Date June 11, 1992
Days to Decision 239 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010