FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K Number: K014201
·
Decision Feb 25, 2002
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
46
Review Days
66
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Basic Information
- Device Name
- AARON REUSABLE ELECTROSURGICAL ELECTRODE
- K Number
- K014201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aaron Medical Industries
- Date Received
- December 21, 2001
- Decision Date
- February 25, 2002
- 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 Aaron Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K062337 | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR | Oct 5, 2006 | Substantially Equivalent |
| K061307 | BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK | Jul 18, 2006 | Substantially Equivalent |
| K060117 | BOVIE BUTTON REMOTE HAND SWITCH | Feb 22, 2006 | Substantially Equivalent |
| K022856 | BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Feb 10, 2003 | Substantially Equivalent |
| K021817 | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V | Jul 11, 2002 | Substantially Equivalent |
| K020579 | AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 | May 13, 2002 | Substantially Equivalent |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | Dec 22, 2000 | Substantially Equivalent |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Jun 27, 2000 | Substantially Equivalent |
| K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | Apr 19, 2000 | Substantially Equivalent |
| K984352 | AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR | Mar 4, 1999 | Substantially Equivalent |