Cleared Traditional

K896723 - CLIP GUN WITH RANEY TYPE SCALP CLIPS
(FDA 510(k) Clearance)

K896723 · Omni Medical Designs · Neurology device

Mar 1990

Decision

114d

Days

Class 2

Risk

K896723 is an FDA 510(k) clearance for the CLIP GUN WITH RANEY TYPE SCALP CLIPS. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).

Submitted by Omni Medical Designs (Livonia, US). The FDA issued a Cleared decision on March 23, 1990, 114 days after receiving the submission on November 29, 1989.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.

Submission Details

510(k) Number	K896723 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1989
Decision Date	March 23, 1990
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—