510(k) K943593
K943593 is an FDA 510(k) premarket notification submitted by Ovamed Corp. for the device "SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 22, 1995. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Ovamed Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1995
- Date Received
- July 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mini Endoscope, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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).