Locking device
FDA 510(k) K202237 · Hangzhou AGS MedTech Co., Ltd.
510(k) numberK202237
Submission
- Device name
- Locking device
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
Hangzhou, CN - Received
- August 7, 2020
- Decision date
- December 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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More from Alton (Shanghai) Medical Instruments Co., Ltd.
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|---|---|---|
| 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 |
| K213578 | Balloon Dilatation CatheterFDF · Traditional | 04/06/2022SE |
| K211787 | HemoclipPKL · Traditional | 03/03/2022SE |
Questions and answers
When was Locking device cleared by the FDA?
Locking device (K202237) received a 510(k) decision of Substantially Equivalent on December 23, 2020, 138 days after the submission was received.
What is the product code of K202237?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.