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ExSept Plus 250 mL

by Angelini Pharma Inc.

ExSept Plus 250 mL (15108) 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 00898021000082), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K082858

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00898021000082 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082858 Date27 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082858 decided 27 May 2009 Active
  • FDA GUDID UDI-DI 00898021000082 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082858
  2. Listed FDA GUDID 00898021000082

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ExSept Plus
Generic name
Antimicrobial wound irrigation solution
Model / Ref / Catalog
250 mL, 15108
Primary DI / UDI-DI
00898021000082
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

Related devices

Category: Antimicrobial wound irrigation solution

Cleared under the same submission (K082858)

Similar devices

Other devices filed under FDA product code FQH (Lavage, Jet).

Other devices from Angelini Pharma Inc.

See all devices from Angelini Pharma Inc. →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)