K102861 is an FDA 510(k) clearance for the SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE). This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by A Plus International, Inc. (Chino, US). The FDA issued a Cleared decision on January 13, 2011, 105 days after receiving the submission on September 30, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K102861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2010 |
| Decision Date | January 13, 2011 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX - Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |