The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Vista Optical Bladeless Laparoscopic Access Port.
| Device ID | K121380 |
| 510k Number | K121380 |
| Device Name: | WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Natalie Smith |
| Correspondent | Natalie Smith 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 | 2012-05-08 |
| Decision Date | 2012-05-25 |
| Summary: | summary |