The following data is part of a premarket notification filed by Bioceptive Inc. with the FDA for Bioceptive Suction Cervical Retractor.
| Device ID | K142204 |
| 510k Number | K142204 |
| Device Name: | Bioceptive Suction Cervical Retractor |
| Classification | Tenaculum, Uterine |
| Applicant | Bioceptive Inc. New Orleans BioInnovation Center, 1441 Canal Street, Ste 228 New Orleans, LA 70112 |
| Contact | Steward B. Davis, M.d. |
| Correspondent | Steward B. Davis, M.d. Bioceptive Inc. New Orleans BioInnovation Center, 1441 Canal Street, Ste 228 New Orleans, LA 70112 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2014-12-19 |