Question 1

Who is the manufacturer of COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

Accepted Answer

Coalescent Surgical submitted the Traditional clearance for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (K003958).

Question 2

What is the FDA product code for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

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 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE cleared by the FDA?

Accepted Answer

Feb 6, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE?

Accepted Answer

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

Record ID	K003958
Device Name	COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
Applicant	Coalescent Surgical
Product Code	FZP · General, Plastic Surgery
Decision Date	Feb 6, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE

Device Facts