K935157 is an FDA 510(k) clearance for the ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES. This device is classified as a Changer, Radiographic Film/cassette (Class II - Special Controls, product code KPX).
Submitted by Regulatory Consultants TO the Medical Device Indus (Sandy, US). The FDA issued a Cleared decision on August 9, 1994, 285 days after receiving the submission on October 28, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1860.
| 510(k) Number | K935157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1993 |
| Decision Date | August 09, 1994 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPX — Changer, Radiographic Film/cassette |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1860 |