What is FDA product code FER?

To examine and perform procedures within the anus and rectum.

Gastroenterology & Urology › DiagnosticAnoscope And Accessories

SleeveLUX 24 Anoscope/Proctoscope

Name: SleeveLUX 24 Anoscope/Proctoscope
Brand: SleeveLUX 24 Anoscope/Proctoscope

The SleeveLUX 24 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal…

Registry build 21.09.26

The SleeveLUX 24 Proctoscope is a class 2, self-illuminating, single use, disposable instrument (medical device) used to assist clinicians treat and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree haemorrhoids. The SleeveLUX 24 Proctoscope must only be used by trained professionals.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FER
Manufacturer	City	Province	Registered as	Device types
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44
Derma Sciences Nantong Incorporation	Development	Jiangsu	Contract manufacturer	19
Well Care (Wuhan) Medical Technology Co., Ltd.	Wuhan	Hubei	Manufacturer	4

Record

Regulatory record for SleeveLUX 24 Anoscope/Proctoscope
Listed by	Haemoband Surgical Ltd, United Kingdom
FDA product code	FER
Device type	Anoscope And Accessories
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Complaint-file establishment, Manufacturer
510(k)	K250645
Record published	2026-04-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment temperature 5 to 30 °C
Packaging	Box of 30

Catalogue Numbers

Catalogue numbers for SleeveLUX 24 Anoscope/Proctoscope
Catalogue number	Size	Status
P2001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Welch Allyn, Inc.	Welch Allyn, Inc.	39
ESI	FTT Medical, Inc.	30
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope	THD SPA	18
Pak-its®	Derma Sciences Canada, Inc.	7
Petrolatum Gauze®	Derma Sciences Canada, Inc.	7
V. Mueller	Steris Corporation	6
GelPOINT Path Transanal Access Platform	Applied Medical Resources Corp.	5
Self-light anoscopes	Sapi MED SPA	5
Cardinal Health	Cardinal Health 200, LLC	4
Retractor	Sapi MED SPA	4
Anoscope	Sapi MED SPA	4
McKesson	Mckesson Medical-Surgical Inc.	4

Showing 12 of 23. All products under Anoscope And Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250645	2025-10-09

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.