The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Sils Stitch Endoscopic Suturing Device.
| Device ID | K090419 |
| 510k Number | K090419 |
| Device Name: | SILS STITCH ENDOSCOPIC SUTURING DEVICE |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Robert Zott |
| Correspondent | Robert Zott COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2009-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521100029 | K090419 | 000 |