Channel Medsystems, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Channel Medsystems, 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 |
|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180032 | PMA | Cerene® Cryotherapy Device | 2019-03-28 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-03-20.
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 Channel Medsystems, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05922657: A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device (Recruiting, started 2023-06-09)
- NCT02842736: A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding (Completed, started 2016-04)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Channel-Markers Medical, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Channel Medsystems, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Channel Medsystems, 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 Channel Medsystems, Inc.?
The most frequent FDA product codes under this applicant name are MNB (Device, Thermal Ablation, Endometrial, 1).
Next steps
- See all 0 Channel Medsystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNB, Channel Medsystems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.