ExSept Plus 200 mL Spray
ExSept Plus 200 mL Spray (15107) is a Class II device made by Angelini Pharma Inc., cleared under FDA 510(k) K082858 on 27 May 2009 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00898021000099), 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 | GUDID listing | Number00898021000099 | Date29 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082858 | Date27 May 2009 | StatusActive |
Official records
- AccessGUDID record 00898021000099
- FDA 510(k) database K082858
Across registries
- FDA 510(k) K082858 decided 27 May 2009 Active
- FDA GUDID UDI-DI 00898021000099 listed 29 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K082858
- Listed FDA GUDID 00898021000099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ExSept Plus
- Generic name
- Antimicrobial wound irrigation solution
- Model / Ref / Catalog
- 200 mL Spray, 15107
- Primary DI / UDI-DI
- 00898021000099
- 510(k) Number
- FDA product code
- FQH
- GMDN term
- Antimicrobial wound irrigation solution
- Device class
- Class II
- Regulation number
- 880.5475
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FQH (Lavage, Jet).
- 0203030000 0203-030-000 by Stryker Corp.
- palaJet ® W-203-B(CM194) 5156831 by Guangzhou Clean Medical Products Manufacturing Corp.
- HY-CHLO(TM)WOUND SCRUB by Patrin Pharma
- CLEANEST W-202-P11(EC) by Guangzhou Clean Medical Products Manufacturing Corp.
- MICRO-AIRE PULSE LAVAGE by MicroAire Surgical Instruments LLC
- HYDROCISION DEBDRIDEMENT SYSTEM by HYDROCISION, INC.
- ERBE 20150-226 by Erbe Elektromedizin GmbH
- ERBE 20150-230 by Erbe Elektromedizin GmbH
- Next Science Irrigation Solution by Next Science LLC
- HELIX HYDRO-JET by Andreas Pein Medizintechnik GmbH