Mcghan Medical Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Mcghan Medical Corp.” (first 1978, latest 1987), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | 7 | 7 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 | 2 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| EWD | Protector, Hearing (Insert) | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| HPZ | Implant, Eye Sphere | 1 | 1 |
| KTB | Device, Iontophoresis, Specific Uses | 1 | 1 |
Review panels
- General and Plastic Surgery (9)
- Ear, Nose and Throat (2)
- General Hospital (1)
- Ophthalmic (1)
- Physical Medicine (1)
Most recent Mcghan Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | GEY | 1987-09-11 | 11 |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | GEY | 1987-09-11 | 11 |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | LCJ | 1987-03-31 | 33 |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | LCJ | 1986-12-24 | 58 |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | LCJ | 1986-12-24 | 58 |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | LCJ | 1986-07-23 | 43 |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | LCJ | 1985-12-24 | 22 |
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | 1985-09-18 | 63 |
| K843704 | MCGHAN TISSUE EXPANDER | LCJ | 1984-10-31 | 40 |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | FPK | 1978-11-22 | 146 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mcghan Medical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mcghan Instrumed Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mcghan Medical Corp.?
FDA lists 14 510(k) clearances under the applicant name “Mcghan Medical Corp.” (first 1978, latest 1987), across 7 product codes in 5 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 Mcghan Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcghan Medical Corp. is 32 days.
Which FDA product codes appear under Mcghan Medical Corp.?
The most frequent FDA product codes under this applicant name are LCJ (Tissue Expander And Accessories, 7); GEY (Motor, Surgical Instrument, Ac-Powered, 2); ETD (Tube, Tympanostomy, 1).
Next steps
- See all 14 Mcghan Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LCJ, Mcghan Medical 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, 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.