K944062 is an FDA 510(k) clearance for the LAPRASCOPIC GRASPER. This device is classified as a Endoscope, Battery-powered And Accessories (Class II - Special Controls, product code GCS).
Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on February 23, 1995, 188 days after receiving the submission on August 19, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K944062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1994 |
| Decision Date | February 23, 1995 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCS — Endoscope, Battery-powered And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |