Cleared Traditional

K873501 - SCISSOR, LEFT
(FDA 510(k) Clearance)

Nov 1987
Decision
63d
Days
Class 1
Risk

K873501 is an FDA 510(k) clearance for the SCISSOR, LEFT. This device is classified as a Scissors, Orthopedic, Surgical (Class I - General Controls, product code HRR).

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987, 63 days after receiving the submission on August 31, 1987.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K873501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date November 02, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code HRR — Scissors, Orthopedic, Surgical
Device Class Class I - General Controls
CFR Regulation 21 CFR 888.4540