Hemoclip
FDA 510(k) clearance K211787 · decided 2022-03-03
Clearance details
- K-number
- K211787
- Device name
- Hemoclip
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-09
- Decision date
- 2022-03-03
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hangzhou AGS MedTech Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.