The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Sils Clincher, Sils Dissector, Sils Grasper, Sils L-hook, Sils Shears.
| Device ID | K091869 |
| 510k Number | K091869 |
| Device Name: | SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523000631 | K091869 | 000 |
| 20884523000617 | K091869 | 000 |
| 20884523000600 | K091869 | 000 |
| 20884523000655 | K091869 | 000 |
| 20884523000648 | K091869 | 000 |
| 20884523000624 | K091869 | 000 |
| 20884523000594 | K091869 | 000 |
| 20884523000587 | K091869 | 000 |