VISION SCIENCES FLEXIBLE ENT SCOPE
FDA 510(k) clearance K100125 · decided 2010-02-25
Clearance details
- K-number
- K100125
- Device name
- VISION SCIENCES FLEXIBLE ENT SCOPE
- Applicant
- Vision-Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-19
- Decision date
- 2010-02-25
- Days to decision
- 37 days
- Clearance type
- Special
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part recall (Z-0928-2012) | Vision-Sciences, Inc. | 2012-01-29 |
| Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endo recall (Z-0929-2012) | Vision-Sciences, Inc. | 2012-01-29 |