510(k) K012598 ยท NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Aug 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Lap Instruments/Graspers/Forceps - HOT
Model #'s:
AUT173016
AUT174301
AUT176643
AUT176643
ETH5DCD
ETH5DCS
ETHEBF01
ETHPOUCH
GYR3000PK
GYR3005PK
GYR3640 and
GYR920005PK
Laparoscopic electric instru Terminated |
NUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.