The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Single Site Flexible Bladeless Obturator.
| Device ID | K101671 |
| 510k Number | K101671 |
| Device Name: | SINGLE SITE FLEXIBLE BLADELESS OBTURATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Angela Bouse |
| Correspondent | Angela Bouse Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-14 |
| Decision Date | 2010-06-25 |
| Summary: | summary |