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).

System 83 Plus · Accessories, Cleaning, for Endoscope → Gastroenterology & Urology

Name: System 83 Plus
Brand: System 83 Plus

1manufacturer

4catalogue numbers in this listing

1510(k) clearance

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 System 83 Plus
Listed by	Wassenburg Medical, Inc., United States
FDA product code	FEB
Device type	Accessories, Cleaning, For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2023-08-11
Record revised	2025-03-19 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	manufacturing date, serial number
Storage	Special storage condition: Keep Dry; Handling environment temperature 0 to 60 °C; Handling environment humidity 10 to 90 % RH; Special storage condition: Do not fork lift; Special storage condition: Fragile
Packaging	Corrugated box, corrugate box
Distribution end date	2023-07-27

Catalogue Numbers

Catalogue numbers for System 83 Plus
Catalogue number	Size	Status
SYSTEM 83 PLUS 9		In distribution
SYSTEM 83 PLUS 2		In distribution
SYSTEM 83 PLUS 2		Withdrawn
SYSTEM 83 PLUS 9		Withdrawn

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
Leak Test AIR Tube	Olympus Medical Systems Corp.	4
Sugi	Questalpha GmbH & Co. KG	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
K241168	2024-12-19

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
2005-12-12	Not classified	PMA	The device was marketed without a 510k	4 units	2013-02-20

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.

System 83 Plus