Disposable Distal Cap

Micro-Tech's Disposable Distal Cap attaches to the end of a compatible endoscope to maintain an appropriate viewing space. It extends beyond the endoscope tip and forms a fixed attachment…

Registry build 21.09.26

Micro-Tech’s Disposable Distal Cap attaches to the end of a compatible endoscope to maintain an appropriate viewing space. It extends beyond the endoscope tip and forms a fixed attachment during the procedure.

The cap is a single-piece silicone component. Different types and internal diameters fit different endoscope tips, with the attachment size selected to match the endoscope’s distal diameter.

Listed Item

Standard type of Disposable Distal Cap, the maximum outer diameter of product is 13.4mm, the length from distal end of endoscopes is 10mm, the diameter of the side hole is 3mm, the total length is 20mm and the diameter of attaching endoscopic distal end is 10.9mm-11.8mm

Fit and Supply

The listed standard configuration has a 13.4 mm maximum outer diameter and extends 10 mm beyond the endoscope tip. Other sizes are available across the family. Each cap is supplied individually packaged, ethylene oxide sterilized and intended for single use.

9manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).

Chinese manufacturers registered for FDA product code FDS
Manufacturer City Province Registered as Device types
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Guangzhou RED Pine Medical Instrument Co., Ltd. Guangzhou Guangdong Manufacturer 8
Sonoscape Medical Corp. Shenzhen Guangdong Manufacturer 7
Sumitomo Bakelite (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 3
Daichuan Medical (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for Disposable Distal Cap
Listed by Micro-Tech (Nanjing) Co., Ltd., China
FDA product code FDS
Device type Gastroscope And Accessories, Flexible/Rigid
Device class Class 2
Regulation 21 CFR 876.1500
Establishment Contract manufacturer, Contract steriliser, Manufacturer
510(k) K243388
Record published 2025-09-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10, case of 10
Sizes Length 4 to 10 mm; outer diameter 3.7 to 15.7 mm

Catalogue Numbers

Catalogue numbers for Disposable Distal Cap
Catalogue number Size Status
VC00134 Length 4 mm In distribution
VC02114 Length 10 mm In distribution
VC02150 Length 10 mm In distribution
VC11150 Length 7 mm In distribution
VC02118 Length 10 mm In distribution
VC11157 Length 7 mm In distribution
VC23037 Length 4.5 mm In distribution
VC34037 Length 6.5 mm In distribution
VC11124 Length 7 mm In distribution
VC11140 Length 7 mm In distribution
VC00114 Length 4 mm In distribution
VC41124 Length 7 mm In distribution
VC00124 Length 4 mm In distribution
VC02134 Length 10 mm In distribution
VC34045 Length 6.5 mm In distribution
VC11114 Length 7 mm In distribution
VC00157 Length 4 mm In distribution
VC11118 Length 7 mm In distribution
VC02157 Length 10 mm In distribution
VC00150 Length 4 mm In distribution
VC02124 Length 10 mm In distribution
VC00140 Length 4 mm In distribution
VC11134 Length 7 mm In distribution
VC02140 Length 10 mm In distribution
VC00118 Length 4 mm In distribution
VC23045 Length 4.5 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pentax Hoya Corporation 72
Fujifilm Fujifilm Corporation 43
Disposable Distal Attachment Olympus Medical Systems Corp. 27
Video Gastroscope Pentax of America, Inc. 20
Gyrus Acmi Gyrus Acmi, Inc. 18
Medisono Medisono, LLC 18
Gastroscope And Accessories, Flexible/Rigid Karl Storz GmbH & Co. KG 17
Distal Attachment Olympus Medical Systems Corp. 14
Disposable EMR KIT Olympus Medical Systems Corp. 12
Fuse® Endochoice, Inc. 11
Evis Exera II Gastrointestinal Videoscope Olympus Medical Systems Corp. 9
Pentax Medical Hoya Corporation 9

Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243388 2025-06-27

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer