FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
K Number: K982212
·
Decision Dec 2, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
16
Review Days
162
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Basic Information
- Device Name
- VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
- K Number
- K982212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synergetics, Inc.
- Date Received
- June 23, 1998
- Decision Date
- December 2, 1998
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Synergetics, Inc.
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|---|---|---|---|
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| 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 |