510(k) clearance

The D-Tip Denudation Pipette

FDA 510(k) source

510(k) number

K261234

Applicant

Allwin Medical Devices, Inc.

Decision date

Oct 9, 2026

Date received

Apr 15, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MQH

Device type

Microtools, Assisted Reproduction (Pipettes)

Device class

Class II

Regulation

21 CFR 884.6130

Advisory committee

Obstetrics/Gynecology

Statement or summary

Statement

Third party

N

Location

Anaheim, CA, US