ENDOSCOPE
FDA 510(k) clearance K933106 · decided 1993-10-19
Clearance details
- K-number
- K933106
- Device name
- ENDOSCOPE
- Applicant
- Origin Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-25
- Decision date
- 1993-10-19
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- ODF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE (K092739) | C-Link Micro Imaging, Inc. | 2010-01-12 |
| POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 (K091962) | Lumenis, Inc. | 2009-09-30 |
| SPYSCOPE ACCESS AND DELIVERY CATHETER (K090170) | Boston Scientific Corp | 2009-02-04 |
| SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (K052194) | Boston Scientific Corp | 2005-08-24 |
| SPYGLASS DIRECT VISULATION PROBE (K050403) | Boston Scientific Corp | 2005-03-04 |
| 5 STAR MEDICAL ENDOSCOPE (K963354) | Five Star Medical, Inc. | 1997-09-08 |
| SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (K943593) | Ovamed Corp. | 1995-03-22 |
| MINI-UB ENDOSCOPES (K941230) | Candela Laser Corp. | 1994-06-17 |
| MODIFIED SERIES 2100 ENDOSCOPES (K912089) | Medical Laser, Inc. | 1991-08-12 |
| CANDELA MINI-UB ENDOSCOPE (K910732) | Candela Laser Corp. | 1991-04-12 |
| LASERTRIPTER MINISCOPE (K874858) | Candela Laser Corp. | 1988-02-19 |
Recalls involving this device
No recalls on record reference this clearance.