510(k) K101534 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
| Applicant | Conmedcorp, Centennial CO, US |
| Decision | Substantially Equivalent, Nov 24, 2010 |
| Received | Jun 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2014 | ConMed Corporation Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: Terminated |
GEI | None listed |
| Nov 15, 2013 | ConMed Corporation ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusio Terminated |
GEI | None listed |
| Nov 15, 2013 | ConMed Corporation ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusio Terminated |
GEI | None listed |
| May 29, 2012 | ConMed Electrosurgery Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany.
The Altrus Thermal Tissue Fusion System is comprised of a ded Terminated |
GEI | None listed |
| May 29, 2012 | ConMed Electrosurgery Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO.
The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source Terminated |
GEI | None listed |
| May 29, 2012 | ConMed Electrosurgery Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog Number 60-9521-001, Sterile/ EO.
The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy sourc Terminated |
GEI | None listed |
| May 29, 2012 | ConMed Electrosurgery Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO.
The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source Terminated |
GEI | None listed |
| May 29, 2012 | ConMed Electrosurgery Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-9511-001, Sterile/EO.
The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy sourc Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.