Cleared Traditional

K890227 - SURGICAL PROBE
(FDA 510(k) Clearance)

K890227 · Kinetic Medical Products · Orthopedic device

Jan 1989

Decision

Days

Class 1

Risk

K890227 is an FDA 510(k) clearance for the SURGICAL PROBE. This device is classified as a Probe (Class I - General Controls, product code HXB).

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989, 9 days after receiving the submission on January 18, 1989.

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

Submission Details

510(k) Number	K890227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1989
Decision Date	January 27, 1989
Days to Decision	9 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—