Specialty Surgical Products, Inc.: FDA clearances and approvals
Specialty Surgical Products, Inc. has 13 FDA 510(k) clearances (first 1997, latest 2014), across 7 product codes in 3 review panels. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 256 |
| 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 | 4 | 4 |
| MIB | Elastomer, Silicone Block | 3 | 3 |
| MRD | Mammary Sizer | 2 | 2 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| FTQ | Prosthesis, Penis, Rigid Rod | 1 | 1 |
Review panels
Most recent Specialty Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140383 | ALLOX2 TISSUE EXPANDERS | LCJ | 2014-10-28 | 256 |
| K070303 | SILICONE TISSUE EXPANDER | LCJ | 2007-06-22 | 142 |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | MRD | 1999-02-12 | 87 |
| K983015 | VIRILIS PENILE PROSTHESIS | FTQ | 1999-02-05 | 161 |
| K982258 | MAMMARY SIZER | MRD | 1998-09-08 | 74 |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | MIB | 1998-08-12 | 61 |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | LCJ | 1998-07-13 | 31 |
| K974653 | SILICONE ELASTOMER SHEETING | MIB | 1998-03-13 | 88 |
| K974654 | SILICONE BLOCKS | MIB | 1998-02-24 | 71 |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | LCJ | 1998-02-06 | 88 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Specialty Surgical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Specialty Surgical Products, Inc. have?
Specialty Surgical Products, Inc. has 13 FDA 510(k) clearances (first 1997, latest 2014), across 7 product codes in 3 review panels.
How long does FDA take to clear Specialty Surgical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Specialty Surgical Products, Inc.'s cleared 510(k)s is 78 days.
What devices does Specialty Surgical Products, Inc. make?
Its most frequent FDA product codes are LCJ (Tissue Expander And Accessories, 4); MIB (Elastomer, Silicone Block, 3); MRD (Mammary Sizer, 2).
Has Specialty Surgical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Specialty Surgical Products, Inc. Related entities may recall under other names.
Next steps
- See all 13 Specialty Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCJ, Specialty Surgical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.