Storz: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Storz” (first 1992, latest 1996), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 226 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| MPA | Endoilluminator | 1 | 1 |
Review panels
- Ophthalmic (5)
- Radiology (1)
Most recent Storz 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960007 | STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR | MPA | 1996-03-26 | 84 |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | HQR | 1996-03-04 | 301 |
| K954340 | STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE | HQC | 1995-12-14 | 87 |
| K930278 | STORZ COMPUSCAN AB | IYO | 1994-02-09 | 384 |
| K926512 | STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE | HQC | 1993-09-09 | 253 |
| K913504 | STORZ MICRO CUTTER 25 GAUGE PACK | HQE | 1992-02-21 | 198 |
Recalls
openFDA lists no recalls under a recalling firm named Storz.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Storz Instrument Co. (101 510(k)s)
- Storz Medical AG (3 510(k)s)
- Storz Ophthalmics, Inc. (2 510(k)s)
- Storz AM Mark GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Storz?
FDA lists 6 510(k) clearances under the applicant name “Storz” (first 1992, latest 1996), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Storz?
The median time from FDA receipt to decision across 510(k)s cleared under the name Storz is 226 days.
Which FDA product codes appear under Storz?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 2); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 1); HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered, 1).
Next steps
- See all 6 Storz clearances with predicates and recalls
- Run predicate analysis for product code HQC, Storz's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.