Atrauclip (Tantalum Hemostatic Clip)

FDA 510(k) K896998 · S.P.K. Technology, Inc.

Substantially Equivalent

510(k) numberK896998

Submission

Device name
Atrauclip (Tantalum Hemostatic Clip)
Applicant
S.P.K. Technology, Inc.
Seal Beach, CA, US
Received
December 12, 1989
Decision date
June 1, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K972745Titanium Hemostatic ClipMCH · Traditional Eisner USA, Inc.10/21/1997SE

More from Eisner USA, Inc.

510(k)DeviceDecision
K896997Atrauclip (Titanium Hemostatic Clip)FZP · Traditional 02/13/1990SE

Questions and answers

When was Atrauclip (Tantalum Hemostatic Clip) cleared by the FDA?

Atrauclip (Tantalum Hemostatic Clip) (K896998) received a 510(k) decision of Substantially Equivalent on June 1, 1990, 171 days after the submission was received.

What is the product code of K896998?

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