The D-Tip Denudation Pipette— 510(k) K261234
Substantially EquivalentAllwin Medical Devices, Inc.
FDA 510(k) clearance K261234 for The D-Tip Denudation Pipette, Substantially Equivalent on 2026-10-09. Applicant: Allwin Medical Devices, Inc.. Device class: 2.
Summary
The D-Tip Denudation Pipette is an assisted reproduction pipette from Allwin Medical Devices, filed under MQH (assisted reproduction microtools, pipettes). The record doesn't describe the tip design or the intended lab step beyond the word "denudation" in the name.
Class II, 21 CFR 884.6130. The Obstetrics/Gynecology panel reviewed it as a Traditional 510(k).
Allwin filed from Anaheim, California. The review clock ran 177 days, from April 15 to October 9, 2026.
Clearance details
- Applicant
- Allwin Medical Devices, Inc.
- Product code
- Product code MQH
- Device class
- Class 2
- Regulation
- 21 CFR 884.6130
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.