Cleared Traditional

K872989 - MICRINS NEEDLE HOLDER
(FDA 510(k) Clearance)

K872989 · Micrins Surgical, Inc. · Orthopedic device

Aug 1987

Decision

21d

Days

Class 1

Risk

K872989 is an FDA 510(k) clearance for the MICRINS NEEDLE HOLDER. This device is classified as a Holder, Needle; Orthopedic (Class I - General Controls, product code HXK).

Submitted by Micrins Surgical, Inc. (Chicago, US). The FDA issued a Cleared decision on August 21, 1987, 21 days after receiving the submission on July 31, 1987.

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

Submission Details

510(k) Number	K872989 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 1987
Decision Date	August 21, 1987
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—