Karl Storz Endoskop GmbH: FDA clearances and approvals
Karl Storz Endoskop GmbH has 11 FDA 510(k) clearances (first 1994, latest 1997), across 9 product codes in 5 review panels. Median 510(k) review time: 64 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| ENZ | Telescope, Laryngeal-Bronchial | 1 | 1 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
| ODB | Endoscopic Contamination Prevention Sheath | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
Most recent Karl Storz Endoskop GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973068 | KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING | GCJ | 1997-11-07 | 81 |
| K961702 | KSEA VAPORIZATION ELECTRODES | FAS | 1996-08-29 | 119 |
| K953368 | LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES | BTR | 1995-09-18 | 62 |
| K943713 | TORCARS,CANNULAE,SHEATHS,OBTURATORS | HET | 1995-06-30 | 333 |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | KNY | 1995-05-24 | 26 |
| K943053 | KSEA SEMM TISSUR PUNCH | HET | 1995-03-21 | 267 |
| K943435 | CHOLANGIOGRAPHY SET | GCJ | 1994-11-07 | 112 |
| K944823 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES | GEI | 1994-11-02 | 34 |
| K943904 | RIGID TELESCOPES | ENZ | 1994-10-14 | 64 |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | ODB | 1994-09-14 | 47 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Karl Storz Endoskop GmbH.
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 Endoskop GmbH have?
Karl Storz Endoskop GmbH has 11 FDA 510(k) clearances (first 1994, latest 1997), across 9 product codes in 5 review panels.
How long does FDA take to clear Karl Storz Endoskop GmbH's 510(k)s?
The median time from FDA receipt to decision across Karl Storz Endoskop GmbH's cleared 510(k)s is 64 days.
What devices does Karl Storz Endoskop GmbH make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); BTR (Tube, Tracheal (W/Wo Connector), 1).
Has Karl Storz Endoskop GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Karl Storz Endoskop GmbH. Related entities may recall under other names.
Next steps
- See all 11 Karl Storz Endoskop GmbH clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Karl Storz Endoskop GmbH'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.