Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KARL STORZ Bipolar Resectoscopes with HF Cable

K-Number: K221893 · 2023-03-17

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2023-03-17
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Bipolar Resectoscopes with HF Cable is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2023-03-17 under approval number K221893. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Bipolar Resectoscopes with HF Cable?

KARL STORZ Bipolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K221893.

When was KARL STORZ Bipolar Resectoscopes with HF Cable approved by the FDA?

KARL STORZ Bipolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2023-03-17, under approval number K221893.

What company makes KARL STORZ Bipolar Resectoscopes with HF Cable?

KARL STORZ Bipolar Resectoscopes with HF Cable is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable?

The FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable is FJL.

Other Devices by Karl Storz Endoscopy America, Inc.

K161555KARL STORZ NAV1 Electromagnetic Navigation System K160044Image1 SPIES System K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces K162992Karl Storz UROMAT E.A.S.I. K162880TIPCAM 1S 3D System K162410TIPCAM 1S 3D System

View all 23 devices →

Related Devices (Code: FJL)

K162979Veloxion SystemCorinth Medtech, Inc. K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc. K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc. K230205Veloxion SystemCorinth Medtech, Inc. K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG

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.

↑