SureStrip Vitrification Straw, SureLock Vitrification Straw— 510(k) K203626
Substantially EquivalentAllwin Medical Devices, Inc.
FDA 510(k) clearance K203626 for SureStrip Vitrification Straw, SureLock Vitrification Straw, Substantially Equivalent on 2021-06-04. Applicant: Allwin Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Allwin Medical Devices, Inc.
- Product code
- Product code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code MQK
view allMore clearances from Allwin Medical Devices, Inc.
view all- K261234 — The D-Tip Denudation Pipette
- K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
- K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
Data sourced from openFDA. This site is unofficial and independent of the FDA.