allFlex Ureteral Catheters, Krait Ureteral Catheters— 510(k) K220730

Clearance details

Applicant

Allwin Medical Devices, Inc.

Product code

Code KOD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2022-03-14

Decision date

2022-10-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Anaheim, CA, US

• K251864 — Rubber Utility Catheter2026-02-23
• K220036 — Wellead Ureteral Catheter2022-12-16
• K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
• K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24
• K180354 — UroGen Ureteral Catheter2018-10-30

• K220781 — ARMADA 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 Catheter2023-05-05
• K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw2021-06-04
• K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators2020-07-01
• K190659 — Ureteral 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 Tip2019-12-02
• K190590 — Allwin 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)2019-11-25

Death

5

Injury

1,129

Malfunction

7,019

Total

8,153

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →