Visitec Co.: FDA clearances and approvals
Visitec Co. has 49 FDA 510(k) clearances (first 1979, latest 1995), across 37 product codes in 6 review panels. Median 510(k) review time: 52 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | 5 | 5 |
| HMX | Cannula, Ophthalmic | 3 | 3 |
| KYG | Device, Irrigation, Ocular Surgery | 3 | 3 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| LZU | Plug, Punctum | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| DRC | Trocar | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FHR | Needle, Gastro-Urology | 1 | 1 |
Plus 27 more product codes.
Review panels
- Ophthalmic (33)
- General and Plastic Surgery (6)
- General Hospital (5)
- Anesthesiology (1)
- Cardiovascular (1)
- Orthopedic (1)
Most recent Visitec Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} | LZU | 1995-10-12 | 87 |
| K945114 | VISITEC SCLERAL PLUG | LXP | 1995-02-23 | 128 |
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | HMT | 1995-02-14 | 83 |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | HQX | 1995-01-17 | 88 |
| K942234 | VISITEC PRECISE-POINT | GAP | 1994-07-12 | 64 |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | HJM | 1994-05-17 | 259 |
| K940210 | VISITEC EYE PAD | EFQ | 1994-03-07 | 52 |
| K933872 | VISI-SPEAR EYE SPONGE | HOZ | 1993-12-27 | 143 |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | FPK | 1992-11-04 | 89 |
| K922530 | VISITEC MICROSURGICAL SUTURE | GAR | 1992-10-20 | 145 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Visitec 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.
Frequently asked questions
How many FDA 510(k) clearances does Visitec Co. have?
Visitec Co. has 49 FDA 510(k) clearances (first 1979, latest 1995), across 37 product codes in 6 review panels.
How long does FDA take to clear Visitec Co.'s 510(k)s?
The median time from FDA receipt to decision across Visitec Co.'s cleared 510(k)s is 52 days.
What devices does Visitec Co. make?
Its most frequent FDA product codes are HOZ (Sponge, Ophthalmic, 5); HMX (Cannula, Ophthalmic, 3); KYG (Device, Irrigation, Ocular Surgery, 3).
Has Visitec Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Visitec Co. Related entities may recall under other names.
Next steps
- See all 49 Visitec Co. clearances with predicates and recalls
- Run predicate analysis for product code HOZ, Visitec 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.