Cleared Traditional

KARL STORZ Bipolar Resectoscopes with HF Cable

K221893 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology
Mar 2023
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K221893 is an FDA 510(k) clearance for the KARL STORZ Bipolar Resectoscopes with HF Cable, a Resectoscope (Class II — Special Controls, product code FJL), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 17, 2023, 261 days after receiving the submission on June 29, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K221893 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2022
Decision Date March 17, 2023
Days to Decision 261 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FJL — Resectoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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