Company ยท US
Starion Instruments
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2007. Name variants (Inc, Corp, punctuation) are merged.
13510(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 |
|---|---|---|---|
| Apr 13, 2007 | K070871 | STARION UNIVERSAL POWER SUPPLY Starion Instruments | HQO |
| Oct 10, 2006 | K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS Starion Instruments | GEI |
| Feb 25, 2005 | K050308 | THERMAL CAUTERY PROBE Starion Instruments | HQR |
| Dec 9, 2004 | K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) Starion Instruments | HQO |
| Oct 20, 2000 | K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR Starion Instruments | HQP |
| Jun 14, 2000 | K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP Starion Instruments | GEI |
| Jun 14, 2000 | K001262 | THERMAL CAUTERY FORCEPS Starion Instruments | GEI |
| Jun 14, 2000 | K000893 | AC POWERED THERMAL CAUTERY UNIT Starion Instruments | HQO |
| Mar 7, 2000 | K000296 | STARION CAUTERY HOOK Starion Instruments | GEI |
| Mar 7, 2000 | K000250 | CAUTERY FORCEPS WITH FOOTSWITCH Starion Instruments | GEI |
| Jan 20, 2000 | K994019 | CAUTERY GRASPER/DISSECTOR Starion Instruments | HQP |
| Oct 5, 1999 | K992460 | CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY Starion Instruments | GEI |
| Jun 3, 1999 | K990728 | THERMAL CAUTERY DEVICE, FORCEPS Starion Instruments | HQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2010 | Starion Instruments The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/ Terminated |
GEI | K062257 |
| Jul 9, 2010 | Starion Instruments Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA
Intended use: Med Terminated |
GEI | K062257 |
| Jul 8, 2010 | Starion Instruments Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA.
Intended use: medical de Terminated |
GEI | None listed |