Pneumatic Wire Tensioner
FDA 510(k) K942760 · Smith & Nephew Richards, Inc.
510(k) numberK942760
Submission
- Device name
- Pneumatic Wire Tensioner
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- June 13, 1994
- Decision date
- September 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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 |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
| K935367 | Tava Wire-DriverHSZ · Traditional | Tava Surgical Instruments | 04/21/1994SE |
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| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
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Questions and answers
When was Pneumatic Wire Tensioner cleared by the FDA?
Pneumatic Wire Tensioner (K942760) received a 510(k) decision of Substantially Equivalent on September 6, 1994, 85 days after the submission was received.
What is the product code of K942760?
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.