Endoscopic Distal Attachment (AF-D series)
FDA 510(k) K242635 · Alton (Shanghai) Medical Instruments Co., Ltd.
510(k) numberK242635
Submission
- Device name
- Endoscopic Distal Attachment (AF-D series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd.
Shanghai, CN - Received
- September 3, 2024
- Decision date
- May 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).
Other 510(k)s with product code FDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | Intuitive Surgical, Inc. | 08/07/2026SE |
| K260573 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 04/21/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | Fujifilm Corporation | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | Fujifilm Corporation | 02/06/2026SE |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | Pentax of America, Inc. | 12/16/2025SE |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | Actuated Medical, Inc. | 10/31/2025SE |
| K251708 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 10/10/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/27/2025SE |
More from Micro-Tech (Nanjing) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | 06/18/2025SE |
| K241679 | Disposable Cytology Brush (AF series)KTI · Traditional | 03/04/2025SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | 10/01/2024SE |
| K231633 | Disposable Hemoclip (AF series)PKL · Traditional | 01/11/2024SE |
| K230925 | Disposable Injection Needle AF seriesFBK · Traditional | 09/27/2023SE |
Questions and answers
When was Endoscopic Distal Attachment (AF-D series) cleared by the FDA?
Endoscopic Distal Attachment (AF-D series) (K242635) received a 510(k) decision of Substantially Equivalent on May 30, 2025, 269 days after the submission was received.
What is the product code of K242635?
The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.