Tik Extraktor

FDA 510(k) K895212 · Instruments of Sweden, Inc.

Substantially Equivalent

510(k) numberK895212

Submission

Device name
Tik Extraktor
Applicant
Instruments of Sweden, Inc.
Stamford, CT, US
Received
August 18, 1989
Decision date
September 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTD – Forceps
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HTD

510(k)DeviceApplicantDecision
K051281The Needle CatcherHTD · Traditional E.D.Medical , Ltd.09/08/2005SE
K974595Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K974594Semkin Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K974593Semkin Insulated Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K913964Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional Marlo Surgical Technology10/23/1991SE
K911180Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional Northgate Technologies, Inc.03/29/1991SE
K890373Hemorrhoidal ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890369Gall Stone ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890263Cilia ForcepsHTD · Traditional Kinetic Medical Products01/27/1989SE
K890262Lung ForcepsHTD · Traditional Kinetic Medical Products01/27/1989SE

Questions and answers

When was Tik Extraktor cleared by the FDA?

Tik Extraktor (K895212) received a 510(k) decision of Substantially Equivalent on September 27, 1989, 40 days after the submission was received.

What is the product code of K895212?

The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.