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FDA 510(k)

allFlex Ureteral Catheters, Krait Ureteral Catheters

K-Number: K220730 · 2022-10-13

ApplicantAllwin Medical Devices, Inc.
Decision Date2022-10-13
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

allFlex Ureteral Catheters, Krait Ureteral Catheters is a medical device manufactured by Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2022-10-13 under approval number K220730. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the allFlex Ureteral Catheters, Krait Ureteral Catheters?

allFlex Ureteral Catheters, Krait Ureteral Catheters is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Allwin Medical Devices, Inc.. The 510(k) number is K220730.

When was allFlex Ureteral Catheters, Krait Ureteral Catheters approved by the FDA?

allFlex Ureteral Catheters, Krait Ureteral Catheters received FDA 510(k) clearance on 2022-10-13, under approval number K220730.

What company makes allFlex Ureteral Catheters, Krait Ureteral Catheters?

allFlex Ureteral Catheters, Krait Ureteral Catheters is manufactured by Allwin Medical Devices, Inc..

What is the FDA product code for allFlex Ureteral Catheters, Krait Ureteral Catheters?

The FDA product code for allFlex Ureteral Catheters, Krait Ureteral Catheters is KOD.

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 K203626SureStrip Vitrification Straw, SureLock Vitrification Straw 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: KOD)

K161344GentleCath Glide Intermittent CatheterConvatec Limited K160877United Urologics Closed System CatheterRobling Medical, Inc. K172924GentleCath Intermittent Urinary CatheterConvatec Limited K180354UroGen Ureteral CatheterUrogen Pharma, Ltd. K181144Angled Tip Ureteral CatheterCook Incorporated K180530Imager II Urology Torque CatheterBoston Scientific Corporation

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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