FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SONOTOME ULTRASONIC ASPIRATOR TIPS
K Number: K010637
·
Decision Apr 20, 2001
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
16
Review Days
46
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Basic Information
- Device Name
- SONOTOME ULTRASONIC ASPIRATOR TIPS
- K Number
- K010637
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synergetics, Inc.
- Date Received
- March 5, 2001
- Decision Date
- April 20, 2001
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
CUSA® Clarity Ultrasonic Surgical Aspirator System
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Synergetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | Jul 10, 2012 | Substantially Equivalent |
| K121675 | VERSAVIT | Jun 21, 2012 | Substantially Equivalent |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Apr 23, 2012 | Substantially Equivalent |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | Dec 7, 2011 | Substantially Equivalent |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | Oct 30, 2009 | Substantially Equivalent |
| K071482 | STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 | Dec 20, 2007 | Substantially Equivalent |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | May 23, 2007 | Substantially Equivalent |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Nov 24, 2003 | Substantially Equivalent |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | Aug 23, 2002 | Substantially Equivalent |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | May 14, 1999 | Substantially Equivalent |