510(k) K070315 ยท KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
| Applicant | Lina Medical Aps, Chapel Hill NC, US |
| Decision | Substantially Equivalent, Oct 30, 2007 |
| Received | Feb 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery D Terminated |
KNF | None listed |
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery D Terminated |
KNF | None listed |
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Di Terminated |
KNF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.