FDA 510(k)

allFlex Ureteral Catheters, Krait Ureteral Catheters

K-Number: K220730 · 2022-10-13

Decision Date2022-10-13

Product CodeKOD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

allFlex Ureteral Catheters, Krait Ureteral Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) 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. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220730.

When did allFlex Ureteral Catheters, Krait Ureteral Catheters receive FDA 510(k) clearance?

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

Who is the listed applicant for allFlex Ureteral Catheters, Krait Ureteral Catheters?

The FDA 510(k) record lists Allwin Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Allwin Medical Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 K203626SureStrip Vitrification Straw, SureLock Vitrification Straw K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators 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)

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Related Devices (Code: KOD)

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.K181144Angled Tip Ureteral CatheterCook Incorporated

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.