The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Surgiport Spiral Sleeve.
| Device ID | K900123 |
| 510k Number | K900123 |
| Device Name: | AUTO SUTURE SURGIPORT SPIRAL SLEEVE |
| Classification | Trocar, Gastro-urology |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FBQ |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-09 |
| Decision Date | 1990-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521099456 | K900123 | 000 |
| 10884521099449 | K900123 | 000 |
| 10884521099432 | K900123 | 000 |
| 10884521099425 | K900123 | 000 |
| 10884521099418 | K900123 | 000 |
| 10884521099111 | K900123 | 000 |