What is FDA product code FEB?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticAccessories, Cleaning, For Endoscope

Advantage Plus Endoscope Reprocessing System

Name: Advantage Plus Endoscope Reprocessing System
Brand: Advantage Plus Endoscope Reprocessing System

Catalogue number 1-2-510.003, listed by Medivators Inc, United States, under Accessories, Cleaning, For Endoscope. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

4510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FEB
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Advantage Plus Endoscope Reprocessing System
Listed by	Medivators Inc, United States
FDA product code	FEB
Device type	Accessories, Cleaning, For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K082988
Record published	2016-09-16
Record revised	2023-02-27 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Advantage Plus Endoscope Reprocessing System
Catalogue number	Size	Status
1-2-510.003		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medivators Hookup	Medivators Inc	333
Evotech™	Advanced Sterilization Products Services Inc.	104
Connecting Tube	Olympus Medical Systems Corp.	47
Accessories, Cleaning, For Endoscope	Steris Corporation	39
Accessories, Cleaning, For Endoscope	Pentax of America, Inc.	24
Accessories, Cleaning, For Endoscope	Richard Wolf Gmbh	16
ASP Aeroflex™	Advanced Sterilization Products Services Inc.	10
Scope Buddy Plus Tubing	Medivators Inc	9
Accessories, Cleaning, For Endoscope	Corporation Steris Canada	8
Scope Assist Flushing Sink (Safs)	Wassenburg Medical, Inc.	6
System 83 Plus	Wassenburg Medical, Inc.	4
Leak Test AIR Tube	Olympus Medical Systems Corp.	4

Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213833	2022-01-14
K172677	2017-12-19
K162128	2016-12-21
K914145	1994-02-22

Recalls Naming This Product

4 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Advantage Plus Endoscope Reprocessing System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Steris Corporation	510(k) number	2024-06-13	Class II	Error in labeling	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may p	37
Steris Corporation	510(k) number	2024-06-13	Class II	Error in labeling	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may p	129
Steris Corporation	510(k) number	2024-06-13	Class II	Error in labeling	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may p	6
Steris Corporation	510(k) number	2023-11-13	Class II	Process control	Identification label on affected hookups could become illegible over time due to the label’s ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of	2545 US; 992 OUS

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2010-06-15	Not classified	Labeling False and Misleading	The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope	185	2011-12-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.