Cleared Traditional

ARTHROSCOPY SUCTION BIOPSY PUNCH

K850527 · T. Korossurgical Instruments Corp. · General & Plastic Surgery
Mar 1985
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K850527 is an FDA 510(k) clearance for the ARTHROSCOPY SUCTION BIOPSY PUNCH, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by T. Korossurgical Instruments Corp. (Westlake, US). The FDA issued a Cleared decision on March 14, 1985, 35 days after receiving the submission on February 7, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K850527 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1985
Decision Date March 14, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTZ — Instrument, Cutting, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800