Cleared Traditional

K873652 - HOOK PROBE #TM-1376
(FDA 510(k) Clearance)

K873652 · Arthropedics, Inc. · Orthopedic device

Nov 1987

Decision

53d

Days

Class 1

Risk

K873652 is an FDA 510(k) clearance for the HOOK PROBE #TM-1376. This device is classified as a Probe (Class I - General Controls, product code HXB).

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987, 53 days after receiving the submission on September 10, 1987.

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

Submission Details

510(k) Number	K873652 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 10, 1987
Decision Date	November 02, 1987
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—