FDA 510(k)

Promisemed VeriEcto Automatic Biopsy Needles

K-Number: K261196 · 2026-05-12

ApplicantPromisemed Hangzhou Meditech Co., Ltd.

Decision Date2026-05-12

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Promisemed VeriEcto Automatic Biopsy Needles is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-05-12 under 510(k) 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. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K261196.

When did Promisemed VeriEcto Automatic Biopsy Needles receive FDA 510(k) clearance?

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

Who is the listed applicant for Promisemed VeriEcto Automatic Biopsy Needles?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Promisemed Hangzhou Meditech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.