510(k) K052194
- Device
- SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K052194
- Product code
- ODF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-24
- Date received
- 2005-08-11
- 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
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- ALLYSON BARFORD
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 1225984
Source Documents#
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 |
| K050403 | SPYGLASS DIRECT VISULATION PROBE | Boston Scientific Corp | 2005-03-04 |
| K963354 | 5 STAR MEDICAL ENDOSCOPE | Five Star Medical, Inc. | 1997-09-08 |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Ovamed Corp. | 1995-03-22 |
| 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#
summary
FDA Review#
Decision Summary