Question 1

Who is the manufacturer of YASARGIL ANEURYSM CLIPS, MODIFICATION?

Accepted Answer

Aesculap, Inc. filed the 510(k) submission for YASARGIL ANEURYSM CLIPS, MODIFICATION (K913765).

Question 2

What is the FDA product code for YASARGIL ANEURYSM CLIPS, MODIFICATION?

Accepted Answer

HCH. It is classified under 21 CFR 882.5200 as a Class 2 device in the Neurology panel.

Question 3

When was YASARGIL ANEURYSM CLIPS, MODIFICATION cleared by the FDA?

Accepted Answer

Mar 11, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for YASARGIL ANEURYSM CLIPS, MODIFICATION?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like YASARGIL ANEURYSM CLIPS, MODIFICATION?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K913765
Device Name	YASARGIL ANEURYSM CLIPS, MODIFICATION
Applicant	Aesculap, Inc.
Product Code	HCH · Neurology
Decision Date	Mar 11, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5200
Device Class	Class 2

YASARGIL ANEURYSM CLIPS, MODIFICATION

Device Facts

Regulatory Classification

Identification