The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Sugiquest Airsealoptical Trocar & Cannula System With Integrated Insufflator Dpis 2000.
| Device ID | K103692 |
| 510k Number | K103692 |
| Device Name: | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
| Classification | Insufflator, Laparoscopic |
| Applicant | SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
| Contact | Daniel Donovan |
| Correspondent | Daniel Donovan SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange, CT 06477 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405988292 | K103692 | 000 |