510(k) K113475 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
| Applicant | Endoscopic Technologies, Inc. D/B/A Estech, San Ramon CA, US |
| Decision | Substantially Equivalent, Mar 20, 2012 |
| Received | Nov 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 Terminated |
OCL | None listed |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 Terminated |
OCL | None listed |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S Terminated |
OCL | None listed |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI Terminated |
OCL | None listed |
| Sep 22, 2016 | AtriCure, Inc. COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003.
Intended to ablate c Terminated |
OCL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.