K143091 is an FDA 510(k) clearance for the Surgisleeve Wound Protector. This device is classified as a Laparoscope, General & Plastic Surgery (Class II - Special Controls, product code GCJ).
Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on November 26, 2014, 29 days after receiving the submission on October 28, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.1500. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K143091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2014 |
| Decision Date | November 26, 2014 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | GCJ — Laparoscope, General & Plastic Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |