510(k) K905747 ยท HGI Electrocautery, Gynecologic (And Accessories)
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
| Applicant | Coopervision Surgical, Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 17, 1991 |
| Received | Dec 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905747
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2014 | CooperSurgical, Inc. CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5
Model Number(s): R2010
Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions Terminated |
HGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.