FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMAL CAUTERY PROBE
K Number: K050308
·
Decision Feb 25, 2005
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
10
Applicant Total
13
Review Days
17
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Basic Information
- Device Name
- THERMAL CAUTERY PROBE
- K Number
- K050308
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starion Instruments
- Date Received
- February 8, 2005
- Decision Date
- February 25, 2005
- Product Code
- HQR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Starion Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | Apr 13, 2007 | Substantially Equivalent |
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS | Oct 10, 2006 | Substantially Equivalent |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | Dec 9, 2004 | Substantially Equivalent |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Oct 20, 2000 | Substantially Equivalent |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | Jun 14, 2000 | Substantially Equivalent |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Jun 14, 2000 | Substantially Equivalent |
| K001262 | THERMAL CAUTERY FORCEPS | Jun 14, 2000 | Substantially Equivalent |
| K000250 | CAUTERY FORCEPS WITH FOOTSWITCH | Mar 7, 2000 | Substantially Equivalent |
| K000296 | STARION CAUTERY HOOK | Mar 7, 2000 | Substantially Equivalent |
| K994019 | CAUTERY GRASPER/DISSECTOR | Jan 20, 2000 | Substantially Equivalent |