Gettig Pharmaceutical Instrument Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gettig Pharmaceutical Instrument Co.” (first 1997, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| EJI | Syringe, Cartridge | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
- General Hospital (4)
- Dental (1)
Most recent Gettig Pharmaceutical Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041232 | GETTIG UNIVERSAL VIAL ACCESS PIN | LHI | 2004-07-22 | 73 |
| K033409 | AMERSHAM HEALTH NEEDLE-GUARD | FMI | 2004-01-21 | 89 |
| K022495 | GETTIG DISPOSABLE SYRINGES | FMF | 2002-10-08 | 71 |
| K000455 | GETTIG GUARD | FMI | 2000-04-19 | 68 |
| K972285 | GETTIG STYRL-JECT DELIVERY SYSTEM | EJI | 1997-09-11 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Gettig Pharmaceutical Instrument Co..
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 Gettig Pharmaceutical Instrument Co.?
FDA lists 5 510(k) clearances under the applicant name “Gettig Pharmaceutical Instrument Co.” (first 1997, latest 2004), 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 Gettig Pharmaceutical Instrument Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gettig Pharmaceutical Instrument Co. is 73 days.
Which FDA product codes appear under Gettig Pharmaceutical Instrument Co.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); EJI (Syringe, Cartridge, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 5 Gettig Pharmaceutical Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Gettig Pharmaceutical Instrument Co.'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.