510(k) K943593
- Device
- SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
- Applicant
- OVAMED CORP.
- 510(k) number
- K943593
- Product code
- ODF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-22
- Date received
- 1994-07-25
- Regulation
- 876.1500
- Classification name
- Mini Endoscope, Gastroenterology-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN ZINK
- Address
- 111 W. Evelyn Ave., Suite 214 Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 1225984
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ODF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | C-Link Micro Imaging, Inc. | 2010-01-12 |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Lumenis, Inc. | 2009-09-30 |
| K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER | Boston Scientific Corp | 2009-02-04 |
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | Boston Scientific Corp | 2005-08-24 |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Boston Scientific Corp | 2005-03-04 |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Five Star Medical, Inc. | 1997-09-08 |
| K941230 | MINI-UB ENDOSCOPES | Candela Laser Corp. | 1994-06-17 |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | 1993-10-19 |
| K912089 | MODIFIED SERIES 2100 ENDOSCOPES | Medical Laser, Inc. | 1991-08-12 |
| K910732 | CANDELA MINI-UB ENDOSCOPE | Candela Laser Corp. | 1991-04-12 |
| K874858 | LASERTRIPTER MINISCOPE | Candela Laser Corp. | 1988-02-19 |
Legacy Summary#
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FDA Review#
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