Cleared Traditional

K873387 - VIDEO ARTHROSCOPE, 1.7MM X 55 MM
(FDA 510(k) Clearance)

Nov 1987
Decision
152d
Days
Class 1
Risk

K873387 is an FDA 510(k) clearance for the VIDEO ARTHROSCOPE, 1.7MM X 55 MM. This device is classified as a Spatula, Orthopedic (Class I - General Controls, product code HXR).

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 25, 1987, 152 days after receiving the submission on June 26, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K873387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1987
Decision Date November 25, 1987
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code HXR — Spatula, Orthopedic
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800