Medco Products, Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medco Products, Co., Inc.” (first 1982, latest 1993), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Medco Products, Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932466 | MEDCHEM SURGICAL DELIVERY SYSTEM | GCJ | 1993-08-09 | 80 |
| K913172 | ENDOSCOPIC DELIVERY SYSTEM | GCJ | 1991-09-06 | 51 |
| K860099 | MEDCO-SONIC NQ-2000 | IMI | 1986-04-09 | 89 |
| K852015 | JYROCHAIR, MODEL SK-H | ITI | 1985-07-19 | 71 |
| K851659 | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE | HAW | 1985-07-01 | 69 |
| K844580 | MEDCOLATOR MODEL HVX | IPF | 1985-02-25 | 94 |
| K842712 | MEDCOLATOR MODEL GX | IPF | 1984-09-19 | 69 |
| K822829 | ROTARY VASCULAR KNIFE | DWS | 1982-11-17 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Medco Products, Co., Inc..
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.
- Medco Instruments, Inc. (1 510(k)s)
- Medco Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medco Products, Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Medco Products, Co., Inc.” (first 1982, latest 1993), across 6 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 Medco Products, Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medco Products, Co., Inc. is 70 days.
Which FDA product codes appear under Medco Products, Co., Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); IPF (Stimulator, Muscle, Powered, 2); DWS (Instruments, Surgical, Cardiovascular, 1).
Next steps
- See all 8 Medco Products, Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Medco Products, Co., Inc.'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.