The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Reusable Obturator.
| Device ID | K121796 |
| 510k Number | K121796 |
| Device Name: | WECK REUSABLE OBTURATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Holly Kornegay |
| Correspondent | Holly Kornegay Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-19 |
| Decision Date | 2012-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704505200 | K121796 | 000 |
| 24026704645224 | K121796 | 000 |
| 44026704559761 | K121796 | 000 |