The following data is part of a premarket notification filed by Covidien Llc with the FDA for Surgisleeve Wound Protector.
| Device ID | K143091 |
| 510k Number | K143091 |
| Device Name: | Surgisleeve Wound Protector |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Covidien LLC 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Michael Koczocik |
| Correspondent | Michael Koczocik Covidien LLC 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 | 2014-10-28 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521521718 | K143091 | 000 |
| 20884521521725 | K143091 | 000 |