Question 1

Who is the manufacturer of BICUT?

Accepted Answer

Berchtold Holding GmbH filed the 510(k) submission for BICUT (K915608).

Question 2

What is the FDA product code for BICUT?

Accepted Answer

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was BICUT cleared by the FDA?

Accepted Answer

Jul 23, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for BICUT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BICUT?

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	K915608
Device Name	BICUT
Applicant	Berchtold Holding GmbH
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 23, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

BICUT

Device Facts

Regulatory Classification

Identification