FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AC POWERED THERMAL CAUTERY UNIT
K Number: K000893
·
Decision Jun 14, 2000
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
13
Review Days
86
Basic Information
- Device Name
- AC POWERED THERMAL CAUTERY UNIT
- K Number
- K000893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STARION INSTRUMENTS
- Date Received
- March 20, 2000
- Decision Date
- June 14, 2000
- Product Code
- HQO
- 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 |
|---|---|---|---|
| HQO | Unit, Cautery, Thermal, 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 |
| K050308 | THERMAL CAUTERY PROBE | Feb 25, 2005 | 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 |
| K001262 | THERMAL CAUTERY FORCEPS | Jun 14, 2000 | Substantially Equivalent |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | Jun 14, 2000 | Substantially Equivalent |
| K000296 | STARION CAUTERY HOOK | Mar 7, 2000 | Substantially Equivalent |
| K000250 | CAUTERY FORCEPS WITH FOOTSWITCH | Mar 7, 2000 | Substantially Equivalent |
| K994019 | CAUTERY GRASPER/DISSECTOR | Jan 20, 2000 | Substantially Equivalent |