GYNECOLOGICAL CYSTO/URETHROSCOPE— 510(k) K800913

Name: FDA 510(k) clearance K800913
Creator: U.S. Food and Drug Administration
Published: 1980-05-14

Substantially Equivalent

Kli

FDA 510(k) clearance K800913 for GYNECOLOGICAL CYSTO/URETHROSCOPE, Substantially Equivalent on 1980-05-14. Applicant: Kli. Device class: 2.

Clearance details

Applicant: Kli
Product code: Code FGC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-21
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FGC

view all

More clearances from Kli

view all

K800822 — CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE1980-06-17
K781913 — INSUFFALATOR LAPARAOSCOPIC1978-12-04
K781109 — FORCEPS, ELECTROSURGICAL1978-09-14
K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPS1978-07-17
K780954 — SCISSORS, HOOK, ELECTROSURGICAL1978-06-22

Adverse events under product code FGC

product code FGC

Malfunction: 1,686
Total: 1,686

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.