Promisemed VeriEcto Automatic Biopsy Needles— 510(k) K261196
Substantially EquivalentPromisemed Hangzhou Meditech Co., Ltd.
FDA 510(k) clearance K261196 for Promisemed VeriEcto Automatic Biopsy Needles, Substantially Equivalent on 2026-05-12. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.
Summary
Promisemed Hangzhou Meditech's Promisemed VeriEcto Automatic Biopsy Needles are filed under KNW, biopsy instruments.
Class II, 21 CFR 876.1075. The General and Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Promisemed filed from Hangzhou City, China. Review took 29 calendar days (April 13 to May 12, 2026).
Clearance details
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Product code
- Product code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hangzhou City, CN
Recent devices under product code KNW
view allMore clearances from Promisemed Hangzhou Meditech Co., Ltd.
view allAdverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.