KSEA CALCUSPLIT— 510(k) K992114

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K992114 for KSEA CALCUSPLIT, Substantially Equivalent on 1999-08-18. Applicant: Karl Storz Endoscopy. Device class: 2.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-22
Decision date: 1999-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFK

K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)2025-03-21
K243032 — EHL Probe (3 models)2025-03-21
K230488 — EL27-Compact; Sterile EHL-Probes2023-08-31
K202813 — URO-TOUCH 9 French Probe2021-06-14
K191124 — Swiss LithoClast Trilogy2019-05-29

More clearances from Karl Storz Endoscopy

K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES2005-01-24
K030848 — PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX2003-06-02
K030009 — KSEA POWERSHAVER SYSTEM S22003-04-02
K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR2003-02-21
K023187 — KSEA SPINOSCOPE2002-12-02

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