Surgitron
FDA 510(k) K990146 · Ellman Intl., Inc.
510(k) numberK990146
Submission
- Device name
- Surgitron
- Applicant
- Ellman Intl., Inc.
Hewlett, NY, US - Received
- January 19, 1999
- Decision date
- March 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K013255 | Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RFGEI · Traditional | 11/07/2001SE |
| K003126 | Bipolar Trigger-Flex ProbeGEI · Traditional | 04/11/2001SE |
| K001986 | Surgitron Iec IIGEI · Traditional | 09/27/2000SE |
| K001407 | Surgitron Iec IIGEI · Traditional | 07/24/2000SE |
| K001253 | Surgitron Iec IIGEI · Traditional | 05/26/2000SE |
| K992382 | Surgitron RadiolaseGEI · Traditional | 10/14/1999SE |
| K980177 | Sugitron Model: IecGEI · Traditional | 07/07/1998SE |
| K980170 | SurgitronGEI · Traditional | 06/29/1998SE |
| K972072 | Surgitron Model Ffpf-EmcGEI · Traditional | 06/19/1997SE |
| K955176 | Dento-SurgeEKZ · Traditional | 04/15/1996SE |
Questions and answers
When was Surgitron cleared by the FDA?
Surgitron (K990146) received a 510(k) decision of Substantially Equivalent on March 17, 1999, 57 days after the submission was received.
What is the product code of K990146?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.