KARL STORZ Endoscopy-America, Inc.: FDA clearances and approvals
KARL STORZ Endoscopy-America, Inc. has 334 FDA 510(k) clearances (first 1980, latest 2026), plus 3 PMA decisions, across 81 product codes in 12 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 112 days, against 113 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 255 |
| 2013 | 4 | 186 |
| 2014 | 4 | 92 |
| 2015 | 2 | 266 |
| 2016 | 2 | 207 |
| 2017 | 5 | 90 |
| 2018 | 3 | 96 |
| 2019 | 4 | 164 |
| 2020 | 4 | 134 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, KARL STORZ Endoscopy-America, Inc.'s cleared 510(k)s took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 47 | 47 |
| HET | Laparoscope, Gynecologic (And Accessories) | 29 | 29 |
| HRX | Arthroscope | 28 | 28 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 27 | 27 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 12 | 12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 12 | 12 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 10 | 10 |
| HIF | Insufflator, Laparoscopic | 9 | 9 |
| HIH | Hysteroscope (And Accessories) | 9 | 9 |
| GWG | Endoscope, Neurological | 8 | 8 |
Plus 71 more product codes.
Review panels
- Gastroenterology and Urology (88)
- General and Plastic Surgery (71)
- Obstetrics and Gynecology (65)
- Ear, Nose and Throat (57)
- Orthopedic (34)
- Neurology (10)
- Cardiovascular (4)
- Radiology (3)
- Anesthesiology (2)
- Dental (1)
- General Hospital (1)
- Ophthalmic (1)
Most recent KARL STORZ Endoscopy-America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | EQN | 2026-05-15 | 270 |
| K223923 | HOPKINS Telescopes | GCJ | 2023-03-30 | 90 |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | FAJ | 2020-10-29 | 29 |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | ERL | 2020-10-22 | 258 |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | FET | 2020-09-01 | 126 |
| K200740 | HD Video Rhino Laryngoscope | EOB | 2020-08-11 | 141 |
| K191357 | Flexible HD Cysto-Urethroscope System | FAJ | 2019-09-18 | 120 |
| K182723 | Flexible HD Cysto-Urethroscope System | FAJ | 2019-04-23 | 207 |
| K182186 | CMOS Video-Rhino-Laryngoscope System | EOB | 2019-03-22 | 221 |
| K183264 | Flex-THOR scope | GCJ | 2019-01-18 | 56 |
324 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050027 | PMA | KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM | 2010-05-28 |
| P020008 | PMA | KARL STORZ AUTOFLUORESCENCE SYSTEM | 2002-12-12 |
| P920051 | PMA | STORZ MODULITH (TM) LITHOTRIPTER | 1995-02-17 |
Recalls
openFDA lists no recalls under a recalling firm named KARL STORZ Endoscopy-America, 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 Endoscopy-America, Inc. have?
KARL STORZ Endoscopy-America, Inc. has 334 FDA 510(k) clearances (first 1980, latest 2026), plus 3 PMA decisions, across 81 product codes in 12 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 88 days. Since 2017: 112 days, versus 113 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, 47); HET (Laparoscope, Gynecologic (And Accessories), 29); HRX (Arthroscope, 28).
Has KARL STORZ Endoscopy-America, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching KARL STORZ Endoscopy-America, Inc. Related entities may recall under other names.
Next steps
- See all 334 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.