Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642C
FDA 510(k) K092761 · Bio Protech, Inc.
510(k) numberK092761
Submission
- Device name
- Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642C
- Applicant
- Bio Protech, Inc.
Dallas, TX, US - Received
- September 9, 2009
- Decision date
- November 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642C cleared by the FDA?
Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642C (K092761) received a 510(k) decision of Substantially Equivalent on November 24, 2009, 76 days after the submission was received.
What is the product code of K092761?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.