Amekina 200 ML Spray

• FDA 510(k) K082858 decided 27 May 2009 Active
• FDA GUDID UDI-DI 00898021000372 listed 7 Feb 2023 Listed

1. 27 May 2009 Cleared FDA 510(k) K082858
2. 7 Feb 2023 Listed FDA GUDID 00898021000372

Trade name

Amekina

Generic name

Antimicrobial wound irrigation solution

Model / Ref / Catalog

200 ML Spray, 419842

Primary DI / UDI-DI

00898021000372

510(k) Number

K082858 ↗

FDA product code

FQH

GMDN term

Antimicrobial wound irrigation solution

Device class

Class II

Regulation number

880.5475

GUDID distribution status

In Commercial Distribution

Category: Antimicrobial wound irrigation solution

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

• BLOWER/MISTER by Cardiothoracic Systems, Inc.
• PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM by Premier Brands of America, Inc.
• FLEXVIEW CO2 BLOWER WITH MIST by Ethicon Endo-Surgery, LLC
• Chase Anastomosis Visualization Device by Chase Medical, Inc.
• RMI SURGICCAL SITE VISUALIZATION WAND by Research Medical, Inc.
• BD Surgiphor Antimicrobial Irrigation System by Becton, Dickinson and Company
• H.V. Pulse Lavage (L31 Series) by Global Medical Products, Ltd.
• VersaJet II Hydrosurgery System by Smith & Nephew, Inc.
• Jetox tubing JNO-014L by TAV - TECH LTD
• ERBE 20150-225 by Erbe Elektromedizin GmbH

• Peracidin™ Gallon

  Class II

  FDA 510(k) K962959 Active Cleared 5 Jun 1998 GUDID on market

• ExSept Plus 250 mL

  Class II

  FDA 510(k) K082858 Active Cleared 27 May 2009 GUDID on market

• Peracidin™ Quarts

  Class II

  FDA 510(k) K962959 Active Cleared 5 Jun 1998 GUDID on market

• ExSept Plus 200 mL Spray

  Class II

  FDA 510(k) K082858 Active Cleared 27 May 2009 GUDID on market

See all devices from Angelini Pharma Inc. →