FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAUTERY GRASPER/DISSECTOR
K Number: K994019
·
Decision Jan 20, 2000
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
13
Review Days
55
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Basic Information
- Device Name
- CAUTERY GRASPER/DISSECTOR
- K Number
- K994019
- 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
- November 26, 1999
- Decision Date
- January 20, 2000
- Product Code
- HQP
- 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 |
|---|---|---|---|
| HQP | Unit, Cautery, Thermal, Battery-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
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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 |
| 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 |