The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Airseal Optical Trocar & Cannula System.
| Device ID | K083211 |
| 510k Number | K083211 |
| Device Name: | AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
| Contact | Kourosh Azarbarzin |
| Correspondent | Kourosh Azarbarzin SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2008-12-15 |
| Summary: | summary |