The following data is part of a premarket notification filed by Tools For Surgery, Llc with the FDA for Siren Sgt.
| Device ID | K220218 |
| 510k Number | K220218 |
| Device Name: | Siren SGT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Tools For Surgery, LLC 8 Technology Drive, #100 East Setauket, NY 11773 -3327 |
| Contact | Arnold R. Leiboff |
| Correspondent | Arnold R. Leiboff Tools For Surgery, LLC 8 Technology Drive, #100 East Setauket, NY 11773 -3327 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2022-01-26 |
| Decision Date | 2022-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002701363 | K220218 | 000 |