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FDA 510(k)

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

K-Number: K200248 · 2020-07-01

ApplicantAllwin Medical Devices, Inc.
Decision Date2020-07-01
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is a medical device manufactured by Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-07-01 under approval number K200248. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is a medical device that received FDA 510(k) clearance on 2020-07-01. It is manufactured by Allwin Medical Devices, Inc.. The 510(k) number is K200248.

When was Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators approved by the FDA?

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators received FDA 510(k) clearance on 2020-07-01, under approval number K200248.

What company makes Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is manufactured by Allwin Medical Devices, Inc..

What is the FDA product code for Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

The FDA product code for Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is MQF.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

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) K203626SureStrip Vitrification Straw, SureLock Vitrification Straw 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

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Related Devices (Code: MQF)

K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated K163318Soules Intrauterine Insemination CatheterCook Incorporated K162878Kitazato ET CathetersKitazato Corporation K162667Kitazato IUI CatheterKitazato Corporation K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, 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.

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