gel-e Flex+
FDA 510(k) clearance K182811 · decided 2019-08-29
Clearance details
- K-number
- K182811
- Device name
- gel-e Flex+
- Applicant
- Gel-E, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-03
- Decision date
- 2019-08-29
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- College Park, MD, 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.
Recalls involving this device
No recalls on record reference this clearance.