510(k) K012571 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
REPROCESSED HARMONIC
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Aug 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Harmonic Scalpel
Model #'s:
ETHACE14S
ETHACE23P
ETHACE36P
ETHCS14C
ETHFCS9
ETHHDH05
ETHLCS-C5 and
ETHLCSC5HA
Intended for use in soft tissue incisions when bleeding control and minimal thermal inju Terminated |
NLQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.