The following data is part of a premarket notification filed by Patton Surgical Corp. with the FDA for Pasport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded Trocar, Cannula Anchor.
| Device ID | K080161 |
| 510k Number | K080161 |
| Device Name: | PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PATTON SURGICAL CORP. 6300 BRIDGEPOINT PKWY. BLDG. 2, STE. 420 Austin, TX 78730 |
| Contact | Michael Patton |
| Correspondent | Michael Patton PATTON SURGICAL CORP. 6300 BRIDGEPOINT PKWY. BLDG. 2, STE. 420 Austin, TX 78730 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-05-29 |
| Summary: | summary |