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510(k) K220730

allFlex Ureteral Catheters, Krait Ureteral Catheters by Allwin Medical Devices, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2022
Date Received
March 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Allwin Medical Devices, Inc.

  • K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz (May 5, 2023)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)
  • K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (July 1, 2020)
  • K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureter (December 2, 2019)
  • K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double (November 25, 2019)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)
  • K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-En (February 1, 2018)