ODF — Mini Endoscope, Gastroenterology-Urology Class II
FDA product code ODF covers "Mini Endoscope, Gastroenterology-Urology", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODF
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K092739 | C-Link Micro Imaging | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DU | Jan 12, 2010 |
| K091962 | Lumenis | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOU | Sep 30, 2009 |
| K090170 | Boston Scientific | SPYSCOPE ACCESS AND DELIVERY CATHETER | Feb 4, 2009 |
| K052194 | Boston Scientific | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Aug 24, 2005 |
| K050403 | Boston Scientific | SPYGLASS DIRECT VISULATION PROBE | Mar 4, 2005 |
| K963354 | Five Star Medical | 5 STAR MEDICAL ENDOSCOPE | Sep 8, 1997 |
| K943593 | Ovamed | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Mar 22, 1995 |
| K941230 | Candela Laser | MINI-UB ENDOSCOPES | Jun 17, 1994 |
| K933106 | Origin Medsystems | ENDOSCOPE | Oct 19, 1993 |
| K912089 | Medical Laser | MODIFIED SERIES 2100 ENDOSCOPES | Aug 12, 1991 |
| K910732 | Candela Laser | CANDELA MINI-UB ENDOSCOPE | Apr 12, 1991 |
| K874858 | Candela Laser | LASERTRIPTER MINISCOPE | Feb 19, 1988 |