510(k) K213578
K213578 is an FDA 510(k) premarket notification submitted by Hangzhou AGS MedTech Co., Ltd. for the device "Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on April 6, 2022. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Hangzhou AGS MedTech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2022
- Date Received
- November 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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).