Aesculap Power Systems (Elan-E & Microtron)
FDA 510(k) K953968 · Aesculap, Inc.
510(k) numberK953968
Submission
- Device name
- Aesculap Power Systems (Elan-E & Microtron)
- Applicant
- Aesculap, Inc.
South San Francisco, CA, US - Received
- August 22, 1995
- Decision date
- February 5, 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
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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 |
| 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 |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | 12/16/2024SE |
| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Aesculap Power Systems (Elan-E & Microtron) cleared by the FDA?
Aesculap Power Systems (Elan-E & Microtron) (K953968) received a 510(k) decision of Substantially Equivalent on February 5, 1996, 167 days after the submission was received.
What is the product code of K953968?
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.