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FDA 510(k)

Promisemed VeriEcto Automatic Biopsy Needles

K-Number: K261196 · 2026-05-12

Decision Date2026-05-12
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Promisemed VeriEcto Automatic Biopsy Needles is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-05-12 under approval number K261196. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed VeriEcto Automatic Biopsy Needles?

Promisemed VeriEcto Automatic Biopsy Needles is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K261196.

When was Promisemed VeriEcto Automatic Biopsy Needles approved by the FDA?

Promisemed VeriEcto Automatic Biopsy Needles received FDA 510(k) clearance on 2026-05-12, under approval number K261196.

What company makes Promisemed VeriEcto Automatic Biopsy Needles?

Promisemed VeriEcto Automatic Biopsy Needles is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed VeriEcto Automatic Biopsy Needles?

The FDA product code for Promisemed VeriEcto Automatic Biopsy Needles is KNW.

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.