Cleared Traditional

K890443 - CASPAR SCALP CLIP, APPLIER
(FDA 510(k) Clearance)

Jun 1989
Decision
139d
Days
Class 2
Risk

K890443 is an FDA 510(k) clearance for the CASPAR SCALP CLIP, APPLIER. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).

Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on June 15, 1989, 139 days after receiving the submission on January 27, 1989.

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

Submission Details

510(k) Number K890443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date June 15, 1989
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code HBO — Clip, Scalp
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.4150