Solosite Gel Conformable Dressing
510(k) K981150
Solosite Gel Conformable Dressing is a medical device (FDA unclassified; FDA product code MGQ, Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic) made by Smith & Nephew, Inc., cleared under FDA 510(k) K981150 on 22 Jun 1998, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981150 | Date22 Jun 1998 | StatusActive |
Official records
- FDA 510(k) database K981150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MGQ
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic).
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- AMBU GEL, HYDROGEL BURN DRESSING by Ambu, Inc.
- MULTIDEX GEL by Lange Medical Products, Inc.
- BURNFREE BURNSOOTHE HYDROGEL by Levtrade Intl. (Pty), Ltd.