Disposable Distal Attachment
The Olympus D-201 Disposable Distal Attachment is a short transparent plastic tube fitted to the end of a compatible endoscope. It maintains a suitable depth of the field of view during…
The Olympus D-201 Disposable Distal Attachment is a short transparent plastic tube fitted to the end of a compatible endoscope. It maintains a suitable depth of the field of view during gastrointestinal endoscopy. The range includes attachments of different diameters to match the scope.
The attachment is secured to the scope tip with medical tape. Most models have a drainage side hole that allows water and blood to leave the attachment during use. The D-201-11802 configuration is the stated exception without that hole.
Sterile Single-Use Accessory
D-201 attachments are supplied sterile after ethylene oxide sterilization and are intended for single use. They are accessories to the endoscope, providing viewing distance at its distal end. Their role is distinct from the endoscope’s imaging electronics or therapeutic instruments passed through its channels.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).
| 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
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FDS |
| Device type | Gastroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K250296 |
| Record published | 2023-04-29 |
| Record revised | 2024-12-23 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D-201-12704 | In distribution | |
| D-201-15004 | In distribution | |
| D-201-12402 | In distribution | |
| D-201-14304 | In distribution | |
| D-201-10704 | In distribution | |
| D-201-15004 | In distribution | |
| D-201-16403 | In distribution | |
| D-201-12402 | In distribution | |
| D-201-11304 | In distribution | |
| D-201-13404 | In distribution | |
| D-201-11804 | In distribution | |
| D-201-12704 | In distribution | |
| D-201-14304 | In distribution | |
| D-201-10704 | In distribution | |
| D-201-15004 | In distribution | |
| D-201-11804 | In distribution | |
| D-201-11804 | In distribution | |
| D-201-11304 | In distribution | |
| D-201-11802 | In distribution | |
| D-201-14304 | In distribution | |
| D-201-11802 | In distribution | |
| D-201-12704 | In distribution | |
| D-201-11304 | In distribution | |
| D-201-13404 | In distribution | |
| D-201-16403 | In distribution | |
| D-201-11802 | In distribution | |
| D-201-10704 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 72 |
| Fujifilm | Fujifilm Corporation | 43 |
| Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 26 |
| 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
| Clearance | Decision date |
|---|---|
| K260824 | 2026-08-27 |
| K260856 | 2026-08-27 |
| K250296 | 2025-05-01 |
| K232997 | 2024-06-19 |
| K123317 | 2012-12-11 |
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.