FDA Product Code
FDA Product Code ODF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | C-Link Micro Imaging, Inc. | 2010-01-12 | Traditional | PDF ↗ |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Lumenis, Inc. | 2009-09-30 | Traditional | PDF ↗ |
| K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Boston Scientific Corp | 2009-02-04 | Traditional | PDF ↗ |
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Boston Scientific Corp | 2005-08-24 | Traditional | PDF ↗ |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Boston Scientific Corp | 2005-03-04 | Traditional | PDF ↗ |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Five Star Medical, Inc. | 1997-09-08 | Traditional | PDF ↗ |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Ovamed Corp. | 1995-03-22 | Traditional | PDF ↗ |
| K941230 | MINI-UB ENDOSCOPES | Candela Laser Corp. | 1994-06-17 | Traditional | PDF ↗ |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | 1993-10-19 | Traditional | PDF ↗ |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Medical Laser, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K910732 | CANDELA MINI-UB ENDOSCOPE | Candela Laser Corp. | 1991-04-12 | Traditional | PDF ↗ |
| K874858 | LASERTRIPTER MINISCOPE | Candela Laser Corp. | 1988-02-19 | Traditional | PDF ↗ |
Product code ODF · Class II · Gastroenterology, Urology. Data: openFDA.