Karl Storz Endoscopy America, Inc.: FDA clearances and approvals
Karl Storz Endoscopy America, Inc. has 30 FDA 510(k) clearances (first 2011, latest 2024), across 21 product codes in 7 review panels. Median 510(k) review time: 166 days. Since 2017 its median was 168 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 19 product recalls by a recalling firm named Karl Storz Endoscopy America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 172 |
| 2016 | 3 | 137 |
| 2017 | 3 | 185 |
| 2018 | 1 | 89 |
| 2019 | 1 | 25 |
| 2020 | 3 | 165 |
| 2021 | 8 | 189 |
| 2022 | 5 | 168 |
| 2023 | 3 | 261 |
| 2024 | 1 | 244 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Karl Storz Endoscopy America, Inc.'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 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| EWY | Mediastinoscope, Surgical | 2 | 2 |
| GWG | Endoscope, Neurological | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
Plus 11 more product codes.
Review panels
- Gastroenterology and Urology (10)
- Ear, Nose and Throat (6)
- General and Plastic Surgery (6)
- General Hospital (3)
- Neurology (2)
- Radiology (2)
- Obstetrics and Gynecology (1)
Most recent Karl Storz Endoscopy America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240506 | KARL STORZ Holders | OCV | 2024-10-22 | 244 |
| K223885 | HOPKINS Telescopes | HIH | 2023-09-14 | 261 |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | GCJ | 2023-06-23 | 133 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | FJL | 2023-03-17 | 261 |
| K221004 | HOPKINS Telescopes | GCJ | 2022-12-20 | 259 |
| K222504 | H1 | GCJ | 2022-11-10 | 84 |
| K213194 | HD Mediastinoscope | EWY | 2022-06-23 | 267 |
| K221174 | Telepack + | FET | 2022-05-13 | 18 |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | FGB | 2022-01-20 | 168 |
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) | EOQ | 2021-12-29 | 128 |
20 earlier clearances. See the full list in Caduvo.
Recalls
19 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2013-11-13.
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 Endoscopy America, Inc. have?
Karl Storz Endoscopy America, Inc. has 30 FDA 510(k) clearances (first 2011, latest 2024), across 21 product codes in 7 review panels.
How long does FDA take to clear Karl Storz Endoscopy America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Karl Storz Endoscopy America, Inc.'s cleared 510(k)s is 166 days. Since 2017: 168 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Karl Storz Endoscopy America, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 4); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3).
Has Karl Storz Endoscopy America, Inc. had device recalls?
openFDA lists 19 product recalls in 7 recall events by a recalling firm whose name matches Karl Storz Endoscopy America, Inc; the most recent began 2013-11-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 30 Karl Storz Endoscopy America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Karl Storz Endoscopy America, 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.