Closure Medical Corp.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Closure Medical Corp.” (first 1998, latest 2001), plus 1 PMA and 1 De Novo decisions, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| EMA | Cement, Dental | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 0 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | 1 | 1 |
| OMD | Cutaneous Tissue Adhesive With Mesh | 1 | 0 |
Review panels
Most recent Closure Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002338 | LIQUIDERM LIQUID ADHESIVE BANDAGE | KMF | 2001-01-29 | 181 |
| K991923 | SOOTHE-N-SEAL CANKER SORE RELIEF | MZW | 1999-09-02 | 87 |
| K980159 | OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 | EMA | 1998-04-09 | 83 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN090005 | De Novo | Cutaneous Tissue Adhesive With Mesh | 2010-04-30 |
| P960052 | PMA | DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE) | 1998-08-26 |
Recalls
openFDA lists no recalls under a recalling firm named Closure Medical Corp..
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 Closure Medical Corp.?
FDA lists 3 510(k) clearances under the applicant name “Closure Medical Corp.” (first 1998, latest 2001), plus 1 PMA and 1 De Novo decisions, across 5 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 Closure Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Closure Medical Corp. is 87 days.
Which FDA product codes appear under Closure Medical Corp.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 1); KMF (Bandage, Liquid, 1); MPN (Tissue Adhesive For The Topical Approximation Of Skin, 1).
Next steps
- See all 3 Closure Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Closure Medical Corp.'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.