K943593 is an FDA 510(k) clearance for the SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM. This device is classified as a Mini Endoscope, Gastroenterology-urology (Class II - Special Controls, product code ODF).
Submitted by Ovamed Corp. (Sunnyvale, US). The FDA issued a Cleared decision on March 22, 1995, 240 days after receiving the submission on July 25, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures In Body Cavities Of The Gi And Gu Tract. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K943593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1994 |
| Decision Date | March 22, 1995 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | ODF — Mini Endoscope, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures In Body Cavities Of The Gi And Gu Tract. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |