K932142 is an FDA 510(k) clearance for the SUCTION GUILLOTINE DEVICE. This device is classified as a Instrument, Biopsy, Suction (Class II - Special Controls, product code FCK).
Submitted by Triton Technology, Inc. (Salem, US). The FDA issued a Cleared decision on September 24, 1993, 144 days after receiving the submission on May 3, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K932142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1993 |
| Decision Date | September 24, 1993 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCK — Instrument, Biopsy, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |