HQPClass II
Unit, Cautery, Thermal, Battery-Powered
21 CFR 886.4115 / Ophthalmic
HQP is the FDA product code for Unit, Cautery, Thermal, Battery-Powered, a class II device type, regulated under 21 CFR 886.4115. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- HQP
- Device name
- Unit, Cautery, Thermal, Battery-Powered
- Regulation
- 21 CFR 886.4115
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 24
- Ingested recalls
- 3
Clearances, product code HQP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 1 |
| 1984 | 4 |
| 1988 | 1 |
| 1994 | 1 |
| 1995 | 5 |
| 1999 | 1 |
| 2000 | 2 |
| 2004 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code HQP| Applicant | Clearances |
|---|---|
| Apyx Medical Corporation | 5 |
| Medical Products Development, Inc. | 4 |
| Suncoast Medical Manufacturers, Inc. | 4 |
| Microline Surgical, Inc | 3 |
| Edward Weck, Inc. | 1 |
| Effner and Spreine Co. | 1 |
| Fiab SpA | 1 |
| Kirwan Surgical Products, LLC | 1 |
| Modern Medical Equipment Mfg., Ltd. | 1 |
| Oxboro Medical Intl., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Ambler Surgical, LLC
- Apyx Medical Corporation
- Aspen Surgical Products, Inc.
- Becton Dickinson & Co
- Fiab SpA
- Grupo American Industries, S.A. de C.V
- Gyrus ACMI, Inc.
- Industrias Apson S.A de C.V
- International Sterilization Laboratory, LLC
- Isomedix Operations Inc
- Kirwan Surgical Products, LLC
- Midwest Sterilization Corp.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.