Decision Date2021-06-04
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device manufactured by Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2021-06-04 under approval number K203626. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SureStrip Vitrification Straw, SureLock Vitrification Straw?
SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Allwin Medical Devices, Inc.. The 510(k) number is K203626.
When was SureStrip Vitrification Straw, SureLock Vitrification Straw approved by the FDA?
SureStrip Vitrification Straw, SureLock Vitrification Straw received FDA 510(k) clearance on 2021-06-04, under approval number K203626.
What company makes SureStrip Vitrification Straw, SureLock Vitrification Straw?
SureStrip Vitrification Straw, SureLock Vitrification Straw is manufactured by Allwin Medical Devices, Inc..
What is the FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw?
The FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw is MQK.
Other Devices by Allwin Medical Devices, Inc.
K190659Ureteral 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
K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
K190522Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K220730allFlex Ureteral Catheters, Krait Ureteral Catheters
K220781ARMADA 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
View all 7 devices →
Related Devices (Code: MQK)
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.