Karl Storz Imaging, Inc.: FDA clearances and approvals
Karl Storz Imaging, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time: 75 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| GCI | Laryngoscope, Endoscope | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
Most recent Karl Storz Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | FET | 2001-04-27 | 185 |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | GCI | 2000-07-17 | 80 |
| K994090 | KARL STORZ AUTOCLAVABLE CAMERA HEAD | FET | 2000-02-04 | 63 |
| K990154 | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | FWF | 1999-06-01 | 133 |
| K974391 | KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM | GCJ | 1998-01-30 | 70 |
| K973252 | KARL STORZ DIRECT COUPLED CAMERA HEAD | FET | 1997-11-24 | 87 |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | HKI | 1996-10-22 | 60 |
| K950862 | KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES | GCJ | 1995-05-24 | 86 |
| K950975 | KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS | FET | 1995-05-11 | 70 |
| K950974 | KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS | FET | 1995-05-11 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Karl Storz Imaging, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Karl Storz Imaging, Inc. have?
Karl Storz Imaging, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2001), across 5 product codes in 3 review panels.
How long does FDA take to clear Karl Storz Imaging, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Karl Storz Imaging, Inc.'s cleared 510(k)s is 75 days.
What devices does Karl Storz Imaging, Inc. make?
Its most frequent FDA product codes are FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 5); GCJ (Laparoscope, General & Plastic Surgery, 2); FWF (Camera, Television, Endoscopic, Without Audio, 1).
Has Karl Storz Imaging, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Karl Storz Imaging, Inc. Related entities may recall under other names.
Next steps
- See all 10 Karl Storz Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FET, Karl Storz Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.