Aesculap Hilan Motor System
FDA 510(k) K973736 · Aesculap, Inc.
510(k) numberK973736
Submission
- Device name
- Aesculap Hilan Motor System
- Applicant
- Aesculap, Inc.
South San Francisco, CA, US - Received
- October 1, 1997
- Decision date
- December 29, 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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| 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 |
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Questions and answers
When was Aesculap Hilan Motor System cleared by the FDA?
Aesculap Hilan Motor System (K973736) received a 510(k) decision of Substantially Equivalent on December 29, 1997, 89 days after the submission was received.
What is the product code of K973736?
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.