FDA applicant

Karl Storz Imaging, Inc.

Goleta, CA10 decisions1995–20010 recalls

FDA records 10 decisions for Karl Storz Imaging, Inc. (Goleta, CA) from 1995 to 2001: 10 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is 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 Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karl Storz Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Karl Storz Imaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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. 370 Karl Storz Endoscopy 35 Karl Storz SE & CO. KG 34 Karl Storz Endoskop GmbH 11 Karl Storz GmbH & Co. (Kst) 1 Karl Storz Lithotripsy-America, Inc. 1 Karl M. Block Co. 1 Karl Leibinger GmbH U. Co. KG 1 Karl Storz Endovision, Inc. 1

Karl Storz Imaging, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Karl”