Storz Instrument Co.: FDA clearances and approvals
Storz Instrument Co. has 101 FDA 510(k) clearances (first 1976, latest 1998), across 46 product codes in 9 review panels. Median 510(k) review time: 76 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 17 | 17 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 16 | 16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
| EPT | Microscope, Surgical | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 3 | 3 |
| HNN | Knife, Ophthalmic | 3 | 3 |
| HNO | Keratome, Ac-Powered | 3 | 3 |
| GXI | Probe, Radiofrequency Lesion | 2 | 2 |
| GXW | Echoencephalograph | 2 | 2 |
Plus 36 more product codes.
Review panels
- Ophthalmic (58)
- General and Plastic Surgery (22)
- Radiology (8)
- Neurology (5)
- Ear, Nose and Throat (2)
- General Hospital (2)
- Orthopedic (2)
- Dental (1)
- Gastroenterology and Urology (1)
Most recent Storz Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | MSR | 1998-06-01 | 140 |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | HQE | 1998-03-23 | 42 |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | MRH | 1997-10-10 | 86 |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | HQC | 1997-06-17 | 60 |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | HQE | 1997-02-03 | 69 |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | HQC | 1996-09-20 | 262 |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | HQE | 1996-09-18 | 258 |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | HQC | 1996-08-29 | 240 |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | HQC | 1996-08-23 | 81 |
| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | HQC | 1996-08-06 | 83 |
91 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Storz Instrument Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Storz Instrument Co.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances does Storz Instrument Co. have?
Storz Instrument Co. has 101 FDA 510(k) clearances (first 1976, latest 1998), across 46 product codes in 9 review panels.
How long does FDA take to clear Storz Instrument Co.'s 510(k)s?
The median time from FDA receipt to decision across Storz Instrument Co.'s cleared 510(k)s is 76 days.
What devices does Storz Instrument Co. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 17); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 16); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 7).
Has Storz Instrument Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Storz Instrument Co. Related entities may recall under other names.
Next steps
- See all 101 Storz Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Storz Instrument Co.'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.