Company ยท US
Superdimension, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2012. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 26, 2012 | K120796 | SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER Superdimension, Inc. | JAK |
| Feb 11, 2011 | K110093 | SUPERDIMENSION MARKER DELIVERY KIT Superdimension, Inc. | JAK |
| Oct 7, 2010 | K102604 | I-LOGIC INREACH SYSTEM Superdimension, Ltd. | JAK |
| Sep 4, 2009 | K092365 | INREACH SYSTEM, MODEL AAS00161-02 Superdimension, Ltd. | JAK |
| Sep 16, 2008 | K082386 | INREACH PLANNING LAPTOP Superdimension, Ltd. | LLZ |
| Jun 11, 2008 | K081379 | MODIFICATION TO INREACH SYSTEM Superdimension, Ltd. | JAK |
| Mar 31, 2008 | K080271 | INREACH SYSTEM Superdimension, Ltd. | JAK |
| Jul 12, 2007 | K071473 | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 Superdimension, Ltd. | EOQ |
| Sep 8, 2006 | K062315 | SUPERDIMENSION/BRONCHUS PREMIUM 2 Superdimension, Ltd. | JAK |
| Nov 14, 2005 | K052852 | SUPERDIMENSION/BRONCHUS PREMIUM Superdimension, Ltd. | JAK |
| Sep 8, 2005 | K052260 | SUPERDIMENSION/BRONCHUS 4.1 Superdimension, Ltd. | JAK |
| Nov 8, 2004 | K042438 | SUPERDIMENSION/BRONCHUS Superdimension, Ltd. | JAK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2012 | superDimension, Inc superDimension Systems AAS00016-xx with Software Version 4.0-4.9.
Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in Terminated |
OGK | K052260 |
| Mar 29, 2007 | SuperDimension, Inc. Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01). Terminated |
JAK | None listed |
| Mar 29, 2007 | SuperDimension, Inc. superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract. Terminated |
JAK | K042438 K052260 +2 |