Cleared Special

K173271 - Aesculap Slim Clip Applier Forceps (FDA 510(k) Clearance)

Nov 2017
Decision
29d
Days
Class 2
Risk

K173271 is an FDA 510(k) clearance for the Aesculap Slim Clip Applier Forceps. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 10, 2017, 29 days after receiving the submission on October 12, 2017.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K173271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2017
Decision Date November 10, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCI — Applier, Aneurysm Clip
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.4175