3M Mini-Driver Electric System
FDA 510(k) K955098 · 3M Company
510(k) numberK955098
Submission
- Device name
- 3M Mini-Driver Electric System
- Applicant
- 3M Company
St. Paul, MN, US - Received
- November 7, 1995
- Decision date
- January 22, 1996
- 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
Other 510(k)s with product code HWE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 01/28/2025SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Mini-Driver Electric System cleared by the FDA?
3M Mini-Driver Electric System (K955098) received a 510(k) decision of Substantially Equivalent on January 22, 1996, 76 days after the submission was received.
What is the product code of K955098?
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.