Go Medical Industries Pty. , Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Go Medical Industries Pty. , Ltd.” (first 1984, latest 2001), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 102 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| GDM | Needle, Aspiration And Injection, Reusable | 2 | 2 |
| HDB | Extractor, Vacuum, Fetal | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| HGE | Amniotome | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- General Hospital (3)
- Obstetrics and Gynecology (3)
- General and Plastic Surgery (2)
Most recent Go Medical Industries Pty. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | FCM | 2001-06-06 | 61 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | FCM | 2000-12-27 | 110 |
| K000263 | GO MEDICAL BALLOON INFUSION SYSTEM | MEB | 2000-05-09 | 102 |
| K910007 | SPRINGFUSOR 10R | FRN | 1993-11-02 | 1035 |
| K900336 | V SET | FPA | 1990-10-04 | 254 |
| K895594 | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | GDM | 1989-10-06 | 21 |
| K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) | KOD | 1989-09-12 | 231 |
| K891465 | OBSTETRIC CUP (MODIFICATION) | HDB | 1989-05-11 | 57 |
| K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES | GDM | 1989-03-22 | 92 |
| K850758 | AMNIGLOVE & AMNICOT | HGE | 1985-04-15 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-09-03.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Go Medical Industries Pty. , Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Go Medical Industries Pty. , Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Go Medical Industries Pty. , Ltd.” (first 1984, latest 2001), across 8 product codes in 4 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 Go Medical Industries Pty. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Go Medical Industries Pty. , Ltd. is 102 days.
Which FDA product codes appear under Go Medical Industries Pty. , Ltd.?
The most frequent FDA product codes under this applicant name are FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 2); GDM (Needle, Aspiration And Injection, Reusable, 2); HDB (Extractor, Vacuum, Fetal, 2).
Next steps
- See all 11 Go Medical Industries Pty. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FCM, Go Medical Industries Pty. , 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.