Mini Endoscope, Gastroenterology-Urology
The Mini Endoscope for Gastroenterology-Urology (product code ODF) is a small-caliber flexible endoscope used to examine and perform procedures in body cavities of the GI and GU tracts, offering access to anatomical locations where standard-sized endoscopes may not reach. If reusable, the device must include validated reprocessing instructions and reprocessing validation data in any 510(k) submission. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODF
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | Jan 12, 2010 | Substantially Equivalent | C-Link Micro Imaging, Inc. |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Sep 30, 2009 | Substantially Equivalent | Lumenis, Inc. |
| K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Feb 04, 2009 | Substantially Equivalent | Boston Scientific Corp |
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Aug 24, 2005 | Substantially Equivalent | Boston Scientific Corp |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Mar 04, 2005 | Substantially Equivalent | Boston Scientific Corp |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Sep 08, 1997 | Substantially Equivalent | Five Star Medical, Inc. |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Mar 22, 1995 | Substantially Equivalent | Ovamed Corp. |
| K941230 | MINI-UB ENDOSCOPES | Jun 17, 1994 | Substantially Equivalent | Candela Laser Corp. |
| K933106 | ENDOSCOPE | Oct 19, 1993 | Substantially Equivalent | Origin Medsystems, Inc. |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Aug 12, 1991 | Substantially Equivalent | Medical Laser, Inc. |
| K910732 | CANDELA MINI-UB ENDOSCOPE | Apr 12, 1991 | Substantially Equivalent | Candela Laser Corp. |
| K874858 | LASERTRIPTER MINISCOPE | Feb 19, 1988 | Substantially Equivalent | Candela Laser Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.