Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)
FDA 510(k) K121441 · Bovie Medical Corporation
510(k) numberK121441
Submission
- Device name
- Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)
- Applicant
- Bovie Medical Corporation
Clearwater, FL, US - Received
- May 15, 2012
- Decision date
- July 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQP – Unit, Cautery, Thermal, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4115
- Specialty
- Ophthalmic
Other 510(k)s with product code HQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series of Battery-Powered CauteryHQP · Traditional | Fiab Spa | 09/01/2009SE |
| K062659 | Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesHQP · Traditional | Kirwan Surgical Products, Inc. | 03/09/2007SE |
| K023506 | Surgical Medical Device CauteryHQP · Traditional | Modern Medical Equipment Mfg., Ltd. | 01/13/2004SE |
| K002547 | Starion Instruments Power Point Cautery Grasper/DissectorHQP · Traditional | Starion Instruments | 10/20/2000SE |
| K994019 | Cautery Grasper/DissectorHQP · Traditional | Starion Instruments | 01/20/2000SE |
| K990728 | Thermal Cautery Device, ForcepsHQP · Traditional | Starion Instruments | 06/03/1999SE |
| K952784 | Oxboro-Medical Cautery Tip CleanerHQP · Traditional | Oxboro Medical Intl., Inc. | 07/13/1995SE |
| K945761 | Low Temperature Cautery Fine Tip, Adjustable, Replaceable TipHQP · Traditional | Aaron Medical Industries | 04/10/1995SE |
| K945763 | Low Temperature Cautery Elongated Fine TipHQP · Traditional | Aaron Medical Industries | 02/07/1995SE |
| K945762 | Low Temperature Cautery Fine Tip, AdjustableHQP · Traditional | Aaron Medical Industries | 02/07/1995SE |
More from Aaron Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…GEI · Traditional | 03/12/2019SE |
| K180211 | FreezpointGEH · Traditional | 03/21/2018SE |
| K170777 | Bovie J-Plasma Precise FLEX HandpieceGEI · Traditional | 05/01/2017SE |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…GEI · Traditional | 03/08/2017SE |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…GEI · Traditional | 07/29/2016SE |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…GEI · Traditional | 06/20/2016SE |
| K152777 | Bovie Disposable Bipolar AblatorGEI · Traditional | 01/15/2016SE |
| K152570 | Bovie J-Plasma Precise 360 HandpieceGEI · Traditional | 11/02/2015SE |
| K151325 | Bovie J-Plasma HandpieceGEI · Traditional | 08/04/2015SE |
| K142975 | Bovie Ultimate High Frequency Electrosurgical GeneratorGEI · Traditional | 12/12/2014SE |
Questions and answers
When was Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip) cleared by the FDA?
Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip) (K121441) received a 510(k) decision of Substantially Equivalent on July 20, 2012, 66 days after the submission was received.
What is the product code of K121441?
The FDA product code is HQP – Unit, Cautery, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.