Polypectomy Snare
FDA 510(k) K172729 · Hangzhou AGS MedTech Co., Ltd.
510(k) numberK172729
Submission
- Device name
- Polypectomy Snare
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
Hangzhou, CN - Received
- September 11, 2017
- Decision date
- May 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K222421 | SphincterotomeKNS · Traditional | 05/03/2023SE |
| K221713 | Polypectomy SnareFDI · Traditional | 03/03/2023SE |
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| K213578 | Balloon Dilatation CatheterFDF · Traditional | 04/06/2022SE |
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Questions and answers
When was Polypectomy Snare cleared by the FDA?
Polypectomy Snare (K172729) received a 510(k) decision of Substantially Equivalent on May 21, 2018, 252 days after the submission was received.
What is the product code of K172729?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.