CORTEK ARTHROSCOPE— 510(k) K000198

Name: FDA 510(k) clearance K000198
Creator: U.S. Food and Drug Administration
Published: 2000-04-11

Substantially Equivalent

Cortek Endoscopy, Inc.

FDA 510(k) clearance K000198 for CORTEK ARTHROSCOPE, Substantially Equivalent on 2000-04-11. Applicant: Cortek Endoscopy, Inc.. Device class: 2.

Clearance details

Applicant: Cortek Endoscopy, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2000-01-21
Decision date: 2000-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palatine, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cortek Endoscopy, Inc.

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K000199 — CORTEK MINI LAPAROSCOPE2000-04-13
K000202 — CORTEK LAPAROSCOPES2000-03-31
K000197 — CORTEK CYSTOSCOPE2000-03-03
K000200 — CORTEK URETHEROSCOPE2000-03-03

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.