The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Modified Surgiquest Airseal Optical Trocar & Cannula System With Integrated Insufflator Dpis 2000.
| Device ID | K121336 |
| 510k Number | K121336 |
| Device Name: | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
| Classification | Insufflator, Laparoscopic |
| Applicant | SURGIQUEST, INC. 333 Quarry Rd Milford, CT 06460 |
| Contact | Daniel Donovan |
| Correspondent | Daniel Donovan SURGIQUEST, INC. 333 Quarry Rd Milford, CT 06460 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-07-03 |
| Summary: | summary |