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

Enspire

Name: enspire
Brand: enspire

Main Basin Plug, STERIS Connection Piece is used with the enspire 3000 Cleaning and Liquid Chemical Sterile Processor.

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

3510(k) clearances naming this product code

6recalls on this code

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 enspire
Listed by	Steris Corporation, United States
FDA product code	FEB
Device type	Accessories, Cleaning, For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K230930
Record published	2024-06-03
Record revised	2025-04-08 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for enspire
Catalogue number	Size	Status
enspire 3000		In distribution
enspire 3000		In distribution
enspire 3000		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
K243433	2024-12-02
K230930	2023-06-30
K181865	2018-12-14

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
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
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	1082
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
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
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
2020-10-07	Class III	Device Design	Potential for cleaning solution intrusion into endoscope	293 units:248 units (USA); 45 units OUS	2021-07-14

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.