Ruggles Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ruggles Corp.” (first 1989, latest 1991), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Neurology (3)
- Orthopedic (2)
Most recent Ruggles Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903485 | TITANIUM MESH | GWO | 1991-02-21 | 205 |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | HBG | 1990-09-20 | 85 |
| K902819 | LAMINECTOMY ROGEUR | LXH | 1990-08-09 | 43 |
| K902850 | ZEPPELIN INSTRUMENTS | HAO | 1990-07-18 | 19 |
| K893415 | TRANS-ORAL DEPTH GAUGE | LYQ | 1989-06-07 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Ruggles Corp..
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 Ruggles Corp.?
FDA lists 5 510(k) clearances under the applicant name “Ruggles Corp.” (first 1989, latest 1991), across 5 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 Ruggles Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ruggles Corp. is 43 days.
Which FDA product codes appear under Ruggles Corp.?
The most frequent FDA product codes under this applicant name are GWO (Plate, Cranioplasty, Preformed, Alterable, 1); HAO (Instrument, Surgical, Non-Powered, 1); HBG (Drills, Burrs, Trephines & Accessories (Manual), 1).
Next steps
- See all 5 Ruggles Corp. clearances with predicates and recalls
- Run predicate analysis for product code GWO, Ruggles Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.