510(k) K910253 ยท HEE Set, Anesthesia, Paracervical
LEEP REDIKIT
| Applicant | CooperSurgical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Apr 18, 1991 |
| Received | Jan 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2015 | CooperSurgical, Inc. CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure
P/N 6061 Terminated |
HEE | None listed |
| Apr 3, 2013 | Cooper Surgical, Inc. LEEP REDIKIT Product No. 6060
In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.