510(k) K050343 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
REPROCESSED HARMONIC SCALPELS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 12, 2005 |
| Received | Feb 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilit Terminated |
NLU | None listed |
| 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.