FDA 510(k)

The D-Tip Denudation Pipette

K-Number: K261234 · 2026-10-09

Decision Date2026-10-09

Product CodeMQH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

The D-Tip Denudation Pipette is the device name listed in this FDA 510(k) record. The listed applicant is Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K261234. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The D-Tip Denudation Pipette?

The D-Tip Denudation Pipette is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K261234.

When did The D-Tip Denudation Pipette receive FDA 510(k) clearance?

The D-Tip Denudation Pipette received FDA 510(k) clearance on 2026-10-09, under 510(k) number K261234.

Who is the listed applicant for The D-Tip Denudation Pipette?

The FDA 510(k) record lists Allwin Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The D-Tip Denudation Pipette?

The FDA product code for The D-Tip Denudation Pipette is MQH.

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Related Devices (Code: MQH)

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbH K161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited K152581LifeGlobal Micro TipsLife Global Group, LLC K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated K102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.

Official Source

View on FDA Database →

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