Question 1

Who is the manufacturer of WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES?

Accepted Answer

Wilo Medizintechnik Lothar Wilberg GmbH filed the 510(k) submission for WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES (K954435).

Question 2

What is the FDA product code for WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES?

Accepted Answer

FZP. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES cleared by the FDA?

Accepted Answer

Oct 23, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES?

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	K954435
Device Name	WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES
Applicant	Wilo Medizintechnik Lothar Wilberg GmbH
Product Code	FZP · General, Plastic Surgery
Decision Date	Oct 23, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES

Device Facts

Regulatory Classification

Identification