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).

Scope Buddy Tubing · Accessories, Cleaning, for Endoscope → Gastroenterology & Urology

Name: Scope Buddy Tubing
Brand: Scope Buddy Tubing

1manufacturer

2catalogue numbers in this listing

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 Scope Buddy Tubing
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)	K162128
Record published	2019-10-10
Record revised	2023-08-09 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
Packaging	Box of 10, case of 3, case of 30
Distribution end date	2023-08-08

Catalogue Numbers

Catalogue numbers for Scope Buddy Tubing
Catalogue number	Size	Status
SB-110-HU1002		Withdrawn
SB-110-HU1001		Withdrawn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
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

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.

Scope Buddy Tubing