510(k) K042384 ยท GZL Electrode, Depth
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
| Applicant | Cyberkinetics, Inc. (Cki), Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 29, 2005 |
| Received | Sep 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2010 | I2s Micro Implantable Systems Llc Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT.
Intended use: The Inserter Wa Terminated |
GWL | None listed |
| Jul 7, 2009 | Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468. Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.