Komet Medical Surgical Power Accesories
FDA 510(k) K930109 · Brassler USA
510(k) numberK930109
Submission
- Device name
- Komet Medical Surgical Power Accesories
- Applicant
- Brassler USA
Great Neck, NY, US - Received
- January 11, 1993
- Decision date
- August 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
Other 510(k)s with product code JDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201274 | Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Smtp Technology Co., Ltd. | 02/19/2021SE |
| K172464 | XD880A Ultrasonic Osteotomy Surgical SystemJDX · Traditional | Morley Research Consortium | 04/24/2018SE |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ HandpieceJDX · Traditional | Satalec-Acteon Group | 05/19/2017SE |
| K153743 | Piezosurgery PlusJDX · Traditional | Mectron S.P.A. | 05/25/2016SE |
| K132848 | Piezosurgery FlexJDX · Traditional | Mectron S.P.A. | 11/29/2013SE |
| K100410 | Piezoelectric SystemJDX · Traditional | Satelec | 04/28/2010SE |
| K093805 | Oscar 3JDX · Traditional | Orthosonics, Ltd. | 02/19/2010SE |
| K083284 | Piezosurgery MedicalJDX · Traditional | Piezosurgery S.R.L. | 04/08/2009SE |
| K083830 | Oscar Bone ResectorJDX · Traditional | Orthosonics, Ltd. | 03/20/2009SE |
| K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional | Sra Developments, Ltd. | 12/19/2007SE |
Questions and answers
When was Komet Medical Surgical Power Accesories cleared by the FDA?
Komet Medical Surgical Power Accesories (K930109) received a 510(k) decision of Substantially Equivalent on August 25, 1993, 226 days after the submission was received.
What is the product code of K930109?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.