Meadox Surgimed, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Meadox Surgimed, Inc.” (first 1984, latest 1995), across 14 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 4 | 4 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| EZN | Dilator, Catheter, Ureteral | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
Plus 4 more product codes.
Review panels
- Gastroenterology and Urology (10)
- Cardiovascular (6)
- General and Plastic Surgery (6)
- General Hospital (2)
Most recent Meadox Surgimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944143 | MS CLASSIQUE BALLOON CATHETER | FGE | 1995-03-13 | 200 |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | KOD | 1995-03-09 | 146 |
| K942382 | MS AMPLATZ EXTRA STIFF GUIDE WIRE | DQX | 1994-08-22 | 95 |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | KNW | 1993-06-09 | 146 |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | KNW | 1991-06-20 | 70 |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | EZN | 1991-03-06 | 107 |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | DQX | 1991-02-25 | 139 |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | EZN | 1991-01-30 | 89 |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | KNW | 1990-07-16 | 42 |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | FMI | 1989-06-20 | 116 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Meadox Surgimed, 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.
- Meadox Medicals, Div. Boston Scientific Corp. (53 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meadox Surgimed, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Meadox Surgimed, Inc.” (first 1984, latest 1995), across 14 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 Meadox Surgimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meadox Surgimed, Inc. is 90 days.
Which FDA product codes appear under Meadox Surgimed, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 4); DQX (Wire, Guide, Catheter, 3); EZN (Dilator, Catheter, Ureteral, 3).
Next steps
- See all 24 Meadox Surgimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Meadox Surgimed, 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.