Ethicon Drill Bit and Drill Guide
FDA 510(k) K944590 · ETHICON, Inc.
510(k) numberK944590
Submission
- Device name
- Ethicon Drill Bit and Drill Guide
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- September 19, 1994
- Decision date
- May 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
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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 |
| K934336 | SpinalplaneHSZ · Traditional | Synvasive Technology, Inc. | 03/10/1995SN |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| 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 |
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Questions and answers
When was Ethicon Drill Bit and Drill Guide cleared by the FDA?
Ethicon Drill Bit and Drill Guide (K944590) received a 510(k) decision of Substantially Equivalent on May 11, 1995, 234 days after the submission was received.
What is the product code of K944590?
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.