K150243 is an FDA 510(k) clearance for the Invictus Medical GelShield. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Invictus Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 1, 2015, 88 days after receiving the submission on February 2, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K150243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2015 |
| Decision Date | May 01, 2015 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMP — Protector, Skin Pressure |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6450 |