Electrosurgical Device, Model 26-2500
FDA 510(k) K935490 · Cameron-Miller, Inc.
510(k) numberK935490
Submission
- Device name
- Electrosurgical Device, Model 26-2500
- Applicant
- Cameron-Miller, Inc.
Chicago, IL, US - Received
- November 15, 1993
- Decision date
- April 1, 1994
- 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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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K944775 | Electrosurgical Unit Model 26-0335GEI · Traditional | 10/11/1994SE |
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| K931437 | Model 80-1983, Electrosurgical GeneratorHGI · Traditional | 05/27/1994SE |
| K854109 | Electrosurgical Devices, 26-0330,26-335,340 & 0345GEI · Traditional | 01/24/1986SE |
| K853972 | Cameron-Miller Model 80-2701, Bipolar CoagulatorGEI · Traditional | 01/24/1986SE |
| K833449 | Hand Controlled Pencil or Switch HandGEI · Traditional | 11/29/1983SE |
| K822092 | Cameron-Miller #40-1516GEI · Traditional | 09/21/1982SE |
| K812702 | TechnicatorGEI · Traditional | 11/05/1981SE |
| K791415 | Model 80-1765 Electrosurgical UnitGEI · Traditional | 10/11/1979SE |
| K781353 | Papillotome Cutting SnareKNS · Traditional | 10/10/1978SE |
Questions and answers
When was Electrosurgical Device, Model 26-2500 cleared by the FDA?
Electrosurgical Device, Model 26-2500 (K935490) received a 510(k) decision of Substantially Equivalent on April 1, 1994, 137 days after the submission was received.
What is the product code of K935490?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.