Surgical Burs and Surgical Drill Bits
FDA 510(k) K972508 · Synvasive Technology, Inc.
510(k) numberK972508
Submission
- Device name
- Surgical Burs and Surgical Drill Bits
- Applicant
- Synvasive Technology, Inc.
El Dorado, CA, US - Received
- July 3, 1997
- Decision date
- August 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K043310 | Synthes (USA) Electric Pen Drive SystemHWE · Traditional | Synthes (Usa) | 01/05/2005SE |
| K022744 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Medical Device Services | 09/18/2002SE |
| K012694 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Adven Medical | 02/04/2002SE |
| K012676 | Reprocessed Used, Disposable Blades, Burs, Bits and TapsHWE · Traditional | Adven Medical | 02/04/2002SE |
| K990816 | Avcore SystemHWE · Traditional | Modular Cutting Systems, Inc. | 09/24/1999SE |
| K973736 | Aesculap Hilan Motor SystemHWE · Traditional | Aesculap, Inc. | 12/29/1997SE |
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Questions and answers
When was Surgical Burs and Surgical Drill Bits cleared by the FDA?
Surgical Burs and Surgical Drill Bits (K972508) received a 510(k) decision of Substantially Equivalent on August 26, 1997, 54 days after the submission was received.
What is the product code of K972508?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.