The following data is part of a premarket notification filed by Bipad Surgical, Inc. with the FDA for Bipad Hand Activated, Disposable Bipolar Electrocautery Cords.
| Device ID | K201833 |
| 510k Number | K201833 |
| Device Name: | BiPad Hand Activated, Disposable Bipolar Electrocautery Cords |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BiPad Surgical, Inc. 110 Ocean Blvd Point Lookout, NY 11569 |
| Contact | Louis Cornacchia |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001107043 | K201833 | 000 |
| 00860001107098 | K201833 | 000 |
| 10860001107033 | K201833 | 000 |
| 00860003991817 | K201833 | 000 |