Reprocessed Used Disposable Arthroscopic Blades and Burs
FDA 510(k) K012694 · Adven Medical
510(k) numberK012694
Submission
- Device name
- Reprocessed Used Disposable Arthroscopic Blades and Burs
- Applicant
- Adven Medical
Lubbock, TX, US - Received
- August 14, 2001
- Decision date
- February 4, 2002
- 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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| K143191 | IntelliSense DrillHWE · Traditional | Mcginley Innovations | 02/20/2015SE |
| K102743 | Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresHWE · Traditional | Ortho Solutions Limited | 01/20/2011SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | The Anspach Effort, Inc. | 01/16/2007SE |
| K050766 | Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional | Zimmer Trabecular | 05/26/2005SE |
| 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 |
| 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 |
| K973560 | Bone Graft HarvesterHWE · Traditional | Ds Mfg., Inc. | 11/12/1997SE |
More from Ds Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021528 | Reprocessed Venodyne Sequential Compression Sleeves / WrapJOW · Traditional | 08/21/2002SE |
| K013987 | Reprocessed Disposable TrocarsKBG · Traditional | 03/01/2002SE |
| K012675 | Reprocessed Used Disposable Sequential Compression Sleeves/WrapsJOW · Traditional | 02/12/2002SE |
| K012676 | Reprocessed Used, Disposable Blades, Burs, Bits and TapsHWE · Traditional | 02/04/2002SE |
| K940501 | Re-Sharpenable Saw BladesGFA · Traditional | 06/28/1994SE |
Questions and answers
When was Reprocessed Used Disposable Arthroscopic Blades and Burs cleared by the FDA?
Reprocessed Used Disposable Arthroscopic Blades and Burs (K012694) received a 510(k) decision of Substantially Equivalent on February 4, 2002, 174 days after the submission was received.
What is the product code of K012694?
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.