allFlex Ureteral Catheters, Krait Ureteral Catheters— 510(k) K220730
Substantially EquivalentAllwin Medical Devices, Inc.
FDA 510(k) clearance K220730 for allFlex Ureteral Catheters, Krait Ureteral Catheters, Substantially Equivalent on 2022-10-13. Applicant: Allwin Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Allwin Medical Devices, Inc.
- Product code
- Product code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code KOD
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view all- K261234 — The D-Tip Denudation Pipette
- 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 Catheter
- K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
- 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 Tip
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.