Cohera Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Cohera Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PJK | Tissue Adhesive For Internal Use | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130023 | PMA | COHERA MEDICAL TISSUGLU | 2015-02-03 |
Recalls
openFDA lists no recalls under a recalling firm named Cohera Medical, 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.
Device clinical trials
An industry sponsor named Cohera Medical, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02958449: Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy (Completed, started 2016-12)
- NCT03481140: Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure (Completed, started 2015-04-21)
- NCT02196519: Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure (Completed, started 2013-04)
- NCT01791504: Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive (Completed, started 2013-03)
- NCT01526954: Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage (Completed, started 2012-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cohera Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Cohera Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Cohera Medical, Inc.?
The most frequent FDA product codes under this applicant name are PJK (Tissue Adhesive For Internal Use, 1).
Next steps
- See all 0 Cohera Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PJK, Cohera Medical, 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.