Titanium Hemostatic Clip

FDA 510(k) K972745 · Eisner USA, Inc.

Substantially Equivalent

510(k) numberK972745

Submission

Device name
Titanium Hemostatic Clip
Applicant
Eisner USA, Inc.
Plymouth, MA, US
Received
July 23, 1997
Decision date
October 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MCH – Clip, Hemostatic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code MCH

510(k)DeviceApplicantDecision
K040148Resolution Hemostasis Clipping DeviceMCH · Traditional Boston Scientific Corp04/22/2004SE
K896998Atrauclip (Tantalum Hemostatic Clip)MCH · Traditional S.P.K. Technology, Inc.06/01/1990SE

Questions and answers

When was Titanium Hemostatic Clip cleared by the FDA?

Titanium Hemostatic Clip (K972745) received a 510(k) decision of Substantially Equivalent on October 21, 1997, 90 days after the submission was received.

What is the product code of K972745?

The FDA product code is MCH – Clip, Hemostatic, a Class II (moderate risk) device regulated under 21 CFR 878.4300.