Micro Surgical Instrument System

FDA 510(k) K885273 · Tava Surgical Instruments

Substantially Equivalent

510(k) numberK885273

Submission

Device name
Micro Surgical Instrument System
Applicant
Tava Surgical Instruments
Van Nuys, CA, US
Received
December 22, 1988
Decision date
January 30, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code HSZ

510(k)DeviceApplicantDecision
K991588EMS Swiss OrthoclastHSZ · Traditional (Ems Sa) Electro Medical Systems07/21/1999SE
K972860Curvtek TSR SystemHSZ · Traditional Biolectron, Inc.10/31/1997SE
K970345Alignment InstrumentHSZ · Traditional Richard Wolf Medical Instruments Corp.04/29/1997SE
K955084Aspach 65,000 (Modification)HSZ · Traditional The Anspach Effort, Inc.01/17/1996SE
K954080Sodem High Speed SystemHSZ · Traditional Sodem Diffusion SA10/16/1995SE
K944590Ethicon Drill Bit and Drill GuideHSZ · Traditional ETHICON, Inc.05/11/1995SE
K934336SpinalplaneHSZ · Traditional Synvasive Technology, Inc.03/10/1995SN
K940276Filter, DiffuserHSZ · Traditional Anspach Mfg., Inc.11/16/1994SE
K942760Pneumatic Wire TensionerHSZ · Traditional Smith & Nephew Richards, Inc.09/06/1994SE
K941681Arthrex Circular Harvesting SawHSZ · Traditional Arthrex, Inc.08/25/1994SE

More from Arthrex, Inc.

510(k)DeviceDecision
K935367Tava Wire-DriverHSZ · Traditional 04/21/1994SE
K940109Tava K-WireHTY · Traditional 02/22/1994SE
K884492Micro Surgical Instrument SystemHSZ · Traditional 11/16/1988SE
K872475Surgical BurGFF · Traditional 07/02/1987SE
K863788SawbladeGFA · Traditional 10/14/1986SE
K854543Pulse LavageFQH · Traditional 01/27/1986SE

Questions and answers

When was Micro Surgical Instrument System cleared by the FDA?

Micro Surgical Instrument System (K885273) received a 510(k) decision of Substantially Equivalent on January 30, 1989, 39 days after the submission was received.

What is the product code of K885273?

The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.