FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSAVIT
K Number: K121675
·
Decision Jun 21, 2012
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
16
Review Days
15
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Basic Information
- Device Name
- VERSAVIT
- K Number
- K121675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synergetics, Inc.
- Date Received
- June 6, 2012
- Decision Date
- June 21, 2012
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Synergetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | Jul 10, 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 |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | Apr 20, 2001 | 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 |