Xomed Thermal Myringotomy System
FDA 510(k) K820157 · Xomed, Inc.
510(k) numberK820157
Submission
- Device name
- Xomed Thermal Myringotomy System
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- January 19, 1982
- Decision date
- March 2, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Aaron Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Xomed Thermal Myringotomy System cleared by the FDA?
Xomed Thermal Myringotomy System (K820157) received a 510(k) decision of Substantially Equivalent on March 2, 1982, 42 days after the submission was received.
What is the product code of K820157?
The FDA product code is HQP – Unit, Cautery, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.