Shelhigh, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shelhigh, Inc.” (first 1997, latest 2003), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 135 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
| GXQ | Dura Substitute | 1 | 1 |
| KRH | Ring, Annuloplasty | 1 | 1 |
Review panels
Most recent Shelhigh, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032893 | SHELHIGH NO-REACT BIOCUFF | FTL | 2003-12-19 | 93 |
| K023940 | SHELHIGH BIORING | KRH | 2003-06-04 | 190 |
| K982101 | SHELHIGH NO-REACT DURA SHIELD | GXQ | 2000-05-02 | 687 |
| K991567 | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. | FTM | 1999-07-14 | 70 |
| K982810 | SHELHIGH NO-REACT VASCUPATCH | DXZ | 1998-10-28 | 78 |
| K981756 | SHELHIGH NO-REACT PNEUMOPLEDGETS | FTL | 1998-08-05 | 79 |
| K974914 | SHELHIGH NO-REACT PERICARDIAL PATCHES | DXZ | 1998-06-03 | 177 |
| K964467 | SHELHIGH PERICARDIAL PATCH | DXZ | 1997-09-23 | 320 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-01-18.
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 Shelhigh, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Shelhigh, Inc.” (first 1997, latest 2003), across 5 product codes in 3 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 Shelhigh, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shelhigh, Inc. is 135 days.
Which FDA product codes appear under Shelhigh, Inc.?
The most frequent FDA product codes under this applicant name are DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 3); FTL (Mesh, Surgical, Polymeric, 2); FTM (Mesh, Surgical, 1).
Next steps
- See all 8 Shelhigh, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXZ, Shelhigh, 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.