FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
K Number: K121441
·
Decision Jul 20, 2012
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
14
Review Days
66
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Basic Information
- Device Name
- CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
- K Number
- K121441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bovie Medical Corporation
- Date Received
- May 15, 2012
- Decision Date
- July 20, 2012
- 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
Other 510(k) clearances with the same product code (HQP), ordered by most recent decision date.
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FDA 510(k)
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THERMAL CAUTERY DEVICE, FORCEPS
FDA 510(k)
FDA Class 2
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Other Clearances by Bovie Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | Mar 12, 2019 | Substantially Equivalent |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | May 1, 2017 | Substantially Equivalent |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | Mar 8, 2017 | Substantially Equivalent |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | Jul 29, 2016 | Substantially Equivalent |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | Jun 20, 2016 | Substantially Equivalent |
| K152777 | Bovie Disposable Bipolar Ablator | Jan 15, 2016 | Substantially Equivalent |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Nov 2, 2015 | Substantially Equivalent |
| K151325 | Bovie J-Plasma Handpiece | Aug 4, 2015 | Substantially Equivalent |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | Dec 12, 2014 | Substantially Equivalent |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Mar 17, 2014 | Substantially Equivalent |