Karl Storz SE & CO. KG: FDA clearances and approvals
Karl Storz SE & CO. KG has 30 FDA 510(k) clearances (first 2018, latest 2026), across 18 product codes in 5 review panels. Median 510(k) review time: 168 days. Since 2017 its median was 168 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 223 |
| 2019 | 0 | — |
| 2020 | 3 | 133 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 4 | 54 |
| 2024 | 5 | 265 |
| 2025 | 7 | 203 |
| 2026 | 10 | 152 |
Review time against the same product codes
Since 2017, Karl Storz SE & CO. KG's cleared 510(k)s took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 4 | 4 |
| OWN | Confocal Optical Imaging | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HIG | Insufflator, Hysteroscopic | 3 | 3 |
| FBO | Cystourethroscope | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| EOX | Esophagoscope (Flexible Or Rigid) | 1 | 1 |
| EWY | Mediastinoscope, Surgical | 1 | 1 |
Plus 8 more product codes.
Review panels
- Gastroenterology and Urology (11)
- General and Plastic Surgery (8)
- Obstetrics and Gynecology (6)
- Ear, Nose and Throat (4)
- Orthopedic (1)
Most recent Karl Storz SE & CO. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261102 | UNIDRIVE Select System | HIH | 2026-09-18 | 168 |
| K260884 | UNIDRIVE Select System | GCJ | 2026-09-01 | 168 |
| K254103 | HOPKINS Telescopes for Arthroscopy | HRX | 2026-08-26 | 250 |
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | HIF | 2026-08-19 | 208 |
| K261706 | Endomat Select (UP220) | HIG | 2026-07-16 | 55 |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | OCZ | 2026-06-03 | 273 |
| K254228 | KARL STORZ Trocars with Valve Seals | GCJ | 2026-05-11 | 136 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | EWY | 2026-03-02 | 59 |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | OWN | 2026-02-26 | 59 |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | OWN | 2026-02-12 | 63 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Karl Storz SE & CO. KG.
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 SE & CO. KG have?
Karl Storz SE & CO. KG has 30 FDA 510(k) clearances (first 2018, latest 2026), across 18 product codes in 5 review panels.
How long does FDA take to clear Karl Storz SE & CO. KG's 510(k)s?
The median time from FDA receipt to decision across Karl Storz SE & CO. KG's cleared 510(k)s is 168 days. Since 2017: 168 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Karl Storz SE & CO. KG make?
Its most frequent FDA product codes are FGB (Ureteroscope And Accessories, Flexible/Rigid, 4); OWN (Confocal Optical Imaging, 4); GCJ (Laparoscope, General & Plastic Surgery, 3).
Has Karl Storz SE & CO. KG had device recalls?
openFDA lists no recalls under a recalling firm name matching Karl Storz SE & CO. KG. Related entities may recall under other names.
Next steps
- See all 30 Karl Storz SE & CO. KG clearances with predicates and recalls
- Run predicate analysis for product code FGB, Karl Storz SE & CO. KG'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.