G.W.B. Intl., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “G.W.B. Intl., Ltd.” (first 1990, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| LZU | Plug, Punctum | 3 | 3 |
| OKS | Lacrimal Stents And Intubation Sets | 3 | 3 |
| HPZ | Implant, Eye Sphere | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Ophthalmic (7)
- Radiology (1)
Most recent G.W.B. Intl., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955671 | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) | OKS | 1996-03-06 | 93 |
| K954094 | OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) | LZU | 1995-10-05 | 42 |
| K950569 | OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} | LZU | 1995-03-14 | 41 |
| K940508 | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) | OKS | 1994-05-04 | 89 |
| K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS | HPZ | 1991-06-18 | 106 |
| K911108 | OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS | LZU | 1991-05-13 | 70 |
| K911109 | OPHTA SIL (R), LACHRYMAL INTUBATION SETS | OKS | 1991-05-01 | 58 |
| K896029 | DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 | IYO | 1990-01-12 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named G.W.B. Intl., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under G.W.B. Intl., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “G.W.B. Intl., Ltd.” (first 1990, latest 1996), across 4 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 G.W.B. Intl., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name G.W.B. Intl., Ltd. is 78 days.
Which FDA product codes appear under G.W.B. Intl., Ltd.?
The most frequent FDA product codes under this applicant name are LZU (Plug, Punctum, 3); OKS (Lacrimal Stents And Intubation Sets, 3); HPZ (Implant, Eye Sphere, 1).
Next steps
- See all 8 G.W.B. Intl., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZU, G.W.B. Intl., Ltd.'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.