Aquagel Lubricating Gel
by Parker Laboratories, Inc. 3 variants
Aquagel Lubricating Gel (57-01-5) is a Class I device made by Parker Laboratories, Inc., cleared under FDA 510(k) K864556 on 1 Dec 1986 and listed in FDA GUDID since 6 Dec 2016 (UDI-DI 20855683006474), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20855683006474 | Date6 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK864556 | Date1 Dec 1986 | StatusActive |
Official records
- AccessGUDID record 20855683006474
- FDA 510(k) database K864556
Across registries
- FDA 510(k) K864556 decided 1 Dec 1986 Active
- FDA GUDID UDI-DI 20855683006474 listed 6 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K864556
- Listed FDA GUDID 20855683006474
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aquagel
- Generic name
- Electrode conductive medium
- Model / Ref / Catalog
- LUBRICATING GEL, 57-01-5
- Primary DI / UDI-DI
- 20855683006474
- 510(k) Number
- FDA product code
- KMJ
- GMDN term
- Electrode conductive medium
- Device class
- Class I
- Regulation number
- 880.6375
- GUDID distribution status
- In Commercial Distribution
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