Tissue Seal, LLC: FDA clearances and approvals
Tissue Seal, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050013 | PMA | HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE | 2007-02-16 |
Recalls
openFDA lists no recalls under a recalling firm named Tissue Seal, LLC.
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 Tissue Seal, LLC have?
Tissue Seal, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Tissue Seal, LLC make?
Its most frequent FDA product codes are MPN (Tissue Adhesive For The Topical Approximation Of Skin, 1).
Has Tissue Seal, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Tissue Seal, LLC. Related entities may recall under other names.
Next steps
- See all 0 Tissue Seal, LLC clearances with predicates and recalls
- Run predicate analysis for product code MPN, Tissue Seal, LLC'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.