The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Conceptus Vari-soft Cath/pirouette Posit Mandrel.
| Device ID | K932387 |
| 510k Number | K932387 |
| Device Name: | CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Contact | Alexis Ball |
| Correspondent | Alexis Ball CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-17 |
| Decision Date | 1995-03-06 |