Cleared Traditional

MEDICON YASARGIL CLIP APPLYING FORCEPS

K010910 · Medicon EG · Neurology
Aug 2001
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K010910 is an FDA 510(k) clearance for the MEDICON YASARGIL CLIP APPLYING FORCEPS, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on August 1, 2001, 128 days after receiving the submission on March 26, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K010910 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2001
Decision Date August 01, 2001
Days to Decision 128 days
Submission Type Traditional
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

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