Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RF
FDA 510(k) K013255 · Ellman Intl., Inc.
510(k) numberK013255
Submission
- Device name
- Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RF
- Applicant
- Ellman Intl., Inc.
Hewlett, NY, US - Received
- September 28, 2001
- Decision date
- November 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K980170 | SurgitronGEI · Traditional | 06/29/1998SE |
| K972072 | Surgitron Model Ffpf-EmcGEI · Traditional | 06/19/1997SE |
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Questions and answers
When was Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RF cleared by the FDA?
Surgitron 120 Iec (Also Known AS Surgitron 4.0 Dual RF (K013255) received a 510(k) decision of Substantially Equivalent on November 7, 2001, 40 days after the submission was received.
What is the product code of K013255?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.