K910875 is an FDA 510(k) clearance for the ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE. This device is classified as a Apparatus, Pneumoperitoneum, Automatic (Class II - Special Controls, product code FDP).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 19, 1991, 18 days after receiving the submission on March 1, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K910875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1991 |
| Decision Date | March 19, 1991 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FDP — Apparatus, Pneumoperitoneum, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |