Spyglass Direct Visulation Probe
FDA 510(k) K050403 · Boston Scientific Corp
510(k) numberK050403
Submission
- Device name
- Spyglass Direct Visulation Probe
- Applicant
- Boston Scientific Corp
Natick,, MA, US - Received
- February 17, 2005
- Decision date
- March 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- ODF – Mini Endoscope, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code ODF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092739 | Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light…ODF · Traditional | C-Link Micro Imaging, Inc. | 01/12/2010SE |
| K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source…ODF · Traditional | Lumenis, Inc. | 09/30/2009SE |
| K090170 | Spyscope Access and Delivery CatheterODF · Traditional | Boston Scientific Corp | 02/04/2009SE |
| K052194 | Spyglass Direct Visualization Probe and OcularODF · Traditional | Boston Scientific Corp | 08/24/2005SE |
| K963354 | 5 Star Medical EndoscopeODF · Traditional | Five Star Medical, Inc. | 09/08/1997SE |
| K943593 | Saratoga Modular Miniature Endoscope SystemODF · Traditional | Ovamed Corp. | 03/22/1995SE |
| K941230 | Mini-Ub EndoscopesODF · Traditional | Candela Laser Corp. | 06/17/1994SE |
| K933106 | EndoscopeODF · Traditional | Origin Medsystems, Inc. | 10/19/1993SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | Medical Laser, Inc. | 08/12/1991SE |
| K910732 | Candela Mini-Ub EndoscopeODF · Traditional | Candela Laser Corp. | 04/12/1991SE |
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Questions and answers
When was Spyglass Direct Visulation Probe cleared by the FDA?
Spyglass Direct Visulation Probe (K050403) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 15 days after the submission was received.
What is the product code of K050403?
The FDA product code is ODF – Mini Endoscope, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.