Cautery Grasper/Dissector
FDA 510(k) K994019 · Starion Instruments
510(k) numberK994019
Submission
- Device name
- Cautery Grasper/Dissector
- Applicant
- Starion Instruments
Saratoga, CA, US - Received
- November 26, 1999
- Decision date
- January 20, 2000
- 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 |
|---|---|---|---|
| K121441 | Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)HQP · Traditional | Bovie Medical Corporation | 07/20/2012SE |
| 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 |
| 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 |
|---|---|---|
| K070871 | Starion Universal Power SupplyHQO · Special | 04/13/2007SE |
| K062257 | Starion Instruments Thermal Litigating ShearsGEI · Special | 10/10/2006SE |
| K050308 | Thermal Cautery ProbeHQR · Special | 02/25/2005SE |
| K043155 | Starion Universal Power Supply (Ups)HQO · Special | 12/09/2004SE |
| K002547 | Starion Instruments Power Point Cautery Grasper/DissectorHQP · Traditional | 10/20/2000SE |
| K001273 | Starion Instruments Power Point Cautery ClampGEI · Traditional | 06/14/2000SE |
| K001262 | Thermal Cautery ForcepsGEI · Traditional | 06/14/2000SE |
| K000893 | Ac Powered Thermal Cautery UnitHQO · Traditional | 06/14/2000SE |
| K000296 | Starion Cautery HookGEI · Traditional | 03/07/2000SE |
| K000250 | Cautery Forceps with FootswitchGEI · Traditional | 03/07/2000SE |
Questions and answers
When was Cautery Grasper/Dissector cleared by the FDA?
Cautery Grasper/Dissector (K994019) received a 510(k) decision of Substantially Equivalent on January 20, 2000, 55 days after the submission was received.
What is the product code of K994019?
The FDA product code is HQP – Unit, Cautery, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.