Balloon Dilatation Catheter
FDA 510(k) K213578 · Hangzhou AGS MedTech Co., Ltd.
510(k) numberK213578
Submission
- Device name
- Balloon Dilatation Catheter
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
Hangzhou, CN - Received
- November 10, 2021
- Decision date
- April 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope 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 colon or rectum 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).
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| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | 08/10/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | 06/24/2026SE |
| K252270 | HemoclipPKL · Traditional | 04/08/2026SE |
| K252271 | HemoclipPKL · Traditional | 11/12/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | 03/20/2025SE |
| K222421 | SphincterotomeKNS · Traditional | 05/03/2023SE |
| K221713 | Polypectomy SnareFDI · Traditional | 03/03/2023SE |
| K213143 | HemoclipPKL · Traditional | 07/12/2022SE |
| K211787 | HemoclipPKL · Traditional | 03/03/2022SE |
| K210406 | Bipolar Coagulation ForecepsKGE · Traditional | 10/05/2021SE |
Questions and answers
When was Balloon Dilatation Catheter cleared by the FDA?
Balloon Dilatation Catheter (K213578) received a 510(k) decision of Substantially Equivalent on April 6, 2022, 147 days after the submission was received.
What is the product code of K213578?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.