Surgipro, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Surgipro, Inc.” (first 1993, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 184 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 3 | 3 |
| FRG | Wrap, Sterilization | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent Surgipro, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934031 | STERILE CENTRAL LINE DRESSING TRAY | FRG | 1994-03-01 | 196 |
| K934028 | STERILE DRESSING CHANGE TRAY | LRO | 1994-02-17 | 184 |
| K934029 | STERILE LACERATION & DEBRIDEMENT TRAYS | LRO | 1994-02-04 | 171 |
| K934030 | STERILE TRACHEOSTOMY TRAY | LRO | 1994-01-26 | 162 |
| K912351 | VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS | LYY | 1993-06-17 | 751 |
Recalls
openFDA lists no recalls under a recalling firm named Surgipro, 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.
- Surgipro Central, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgipro, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Surgipro, Inc.” (first 1993, latest 1994), across 3 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 Surgipro, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgipro, Inc. is 184 days.
Which FDA product codes appear under Surgipro, Inc.?
The most frequent FDA product codes under this applicant name are LRO (General Surgery Tray, 3); FRG (Wrap, Sterilization, 1); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 5 Surgipro, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, Surgipro, 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 (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.