Question 1

Who is the manufacturer of YASARGIL ANEURYSM CLIPS?

Accepted Answer

Aesculap Instruments Corp. filed the 510(k) submission for YASARGIL ANEURYSM CLIPS (K772200).

Question 2

What is the FDA product code for YASARGIL ANEURYSM CLIPS?

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 cleared by the FDA?

Accepted Answer

Dec 8, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for YASARGIL ANEURYSM CLIPS?

Accepted Answer

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

Question 5

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

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	K772200
Device Name	YASARGIL ANEURYSM CLIPS
Applicant	Aesculap Instruments Corp.
Product Code	HCH · Neurology
Decision Date	Dec 8, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5200
Device Class	Class 2

YASARGIL ANEURYSM CLIPS

Device Facts

Regulatory Classification

Identification