510(k) Report

FDA applicant

Karl Storz Endoscopy

Culver City, CA35 decisions1995–20053 recalls

FDA records 35 decisions for Karl Storz Endoscopy (Culver City, CA) from 1995 to 2005: 35 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Karl Storz Endoscopy’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karl Storz Endoscopy since 2007.

Recalls per year

1in 2024

2013: 12022: 12024: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Karl Storz Endoscopy by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery6decisions
  • HRXArthroscope5decisions
  • HIHHysteroscope (And Accessories)3decisions
  • FGBUreteroscope And Accessories, Flexible/Rigid2decisions
  • GWGEndoscope, Neurological2decisions
  • HWCScrew, Fixation, Bone2decisions

Also: ETA (1), FBN (1), OCX (1), GEI (1), HIG (1), EOB (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K936231The Karl Storz Hamou EndomatKarl Storz Endoscopy · 19954cite it
  • K030009Ksea Powershaver System S2Karl Storz Endoscopy · 20033cite it
  • K981458Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001RK, 11002BC…Karl Storz Endoscopy · 19982cite it
  • K970427Ksea Uretero-Reno-Fiberscope and Nephro-FiberscopeKarl Storz Endoscopy · 19972cite it
  • K943052Arthroscopic TelescopesKarl Storz Endoscopy · 19952cite it
  • K010569Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpKarl Storz Endoscopy · 20012cite it

What has FDA decided for it lately?

  • K043375Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005
  • K030848Perforated Bioabsorbable Interference Screw MegafixKarl Storz Endoscopy · 2003
  • K030009Ksea Powershaver System S2Karl Storz Endoscopy · 20031 recall
  • K023924Autocon II 200 Electrosurgical GeneratorKarl Storz Endoscopy · 2003
  • K023187Ksea SpinoscopeKarl Storz Endoscopy · 2002
  • K011700Modulith SLK LithotripterKarl Storz Endoscopy · 2002
  • K021776Ksea Quadro SwitchKarl Storz Endoscopy · 2002
  • K013107Bioabsorbable Interference Screw MegafixKarl Storz Endoscopy · 2002

All 35 as Karl Storz Endoscopy →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K0300094.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full…Oct 11, 2024Class II
  • K98290511278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible…Apr 1, 2022Class II
  • K832010Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. "…Nov 13, 2013Class II

Other applicant names beginning “Karl”

FDA records each applicant name separately; these may or may not be the same firm.

KARL STORZ Endoscopy-America, Inc. 370Karl Storz SE & CO. KG 34Karl Storz Endoskop GmbH 11Karl Storz Imaging, Inc. 10Karl Storz GmbH & Co. (Kst) 1Karl Storz Lithotripsy-America, Inc. 1Karl M. Block Co. 1Karl Leibinger GmbH U. Co. KG 1Karl Storz Endovision, Inc. 1