Filter, Diffuser

Q: When was Filter, Diffuser cleared by the FDA?

Filter, Diffuser (K940276) received a 510(k) decision of Substantially Equivalent on November 16, 1994, 299 days after the submission was received.

Q: What is the product code of K940276?

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.

FDA 510(k) K940276 · Anspach Mfg., Inc.

Substantially Equivalent

510(k) numberK940276

Submission

Device name: Filter, Diffuser
Applicant: Anspach Mfg., Inc.
Palm Beach Gardens, FL, US
Received: January 21, 1994
Decision date: November 16, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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)	Device	Applicant	Decision
K991588	EMS Swiss OrthoclastHSZ · Traditional	(Ems Sa) Electro Medical Systems	07/21/1999SE
K972860	Curvtek TSR SystemHSZ · Traditional	Biolectron, Inc.	10/31/1997SE
K970345	Alignment InstrumentHSZ · Traditional	Richard Wolf Medical Instruments Corp.	04/29/1997SE
K955084	Aspach 65,000 (Modification)HSZ · Traditional	The Anspach Effort, Inc.	01/17/1996SE
K954080	Sodem High Speed SystemHSZ · Traditional	Sodem Diffusion SA	10/16/1995SE
K944590	Ethicon Drill Bit and Drill GuideHSZ · Traditional	ETHICON, Inc.	05/11/1995SE
K934336	SpinalplaneHSZ · Traditional	Synvasive Technology, Inc.	03/10/1995SN
K942760	Pneumatic Wire TensionerHSZ · Traditional	Smith & Nephew Richards, Inc.	09/06/1994SE
K941681	Arthrex Circular Harvesting SawHSZ · Traditional	Arthrex, Inc.	08/25/1994SE
K935367	Tava Wire-DriverHSZ · Traditional	Tava Surgical Instruments	04/21/1994SE

More from Tava Surgical Instruments

510(k)	Device	Decision
K925328	Anspach Bone Rivet, Anspach Suture AnchorHWC · Traditional	10/27/1993SE
K905027	Cup OutHSZ · Traditional	02/05/1991SE

Questions and answers

When was Filter, Diffuser cleared by the FDA?

Filter, Diffuser (K940276) received a 510(k) decision of Substantially Equivalent on November 16, 1994, 299 days after the submission was received.

What is the product code of K940276?

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.