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 |