Oxboro-Medical Cautery Tip Cleaner
FDA 510(k) K952784 · Oxboro Medical Intl., Inc.
510(k) numberK952784
Submission
- Device name
- Oxboro-Medical Cautery Tip Cleaner
- Applicant
- Oxboro Medical Intl., Inc.
Ham Lake, MN, US - Received
- June 19, 1995
- Decision date
- July 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K994019 | Cautery Grasper/DissectorHQP · Traditional | Starion Instruments | 01/20/2000SE |
| K990728 | Thermal Cautery Device, ForcepsHQP · Traditional | Starion Instruments | 06/03/1999SE |
| 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 |
|---|---|---|
| K953068 | Oxboro-Medical Foam Instrument HolderKCT · Traditional | 01/23/1996SE |
| K952787 | Foam Instrument GuardKCT · Traditional | 12/28/1995SE |
| K952783 | Oxboro-Medical Pin CoversLRN · Traditional | 09/15/1995SE |
| K880028 | Omed Disposable ScalpelGDX · Traditional | 01/29/1988SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | 01/29/1988SE |
Questions and answers
When was Oxboro-Medical Cautery Tip Cleaner cleared by the FDA?
Oxboro-Medical Cautery Tip Cleaner (K952784) received a 510(k) decision of Substantially Equivalent on July 13, 1995, 24 days after the submission was received.
What is the product code of K952784?
The FDA product code is HQP – Unit, Cautery, Thermal, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4115.