K960040 is an FDA 510(k) clearance for the SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on April 29, 1996, 118 days after receiving the submission on January 2, 1996.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K960040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1996 |
| Decision Date | April 29, 1996 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |