HQP — Unit, Cautery, Thermal, Battery-Powered Class II
FDA product code HQP covers "Unit, Cautery, Thermal, Battery-Powered", a Class II medical device regulated under 21 CFR 886.4115. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQP
- Device Class
- Class II
- Regulation Number
- 886.4115
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121441 | bovie medical corporation | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN | July 20, 2012 |
| K083428 | fiab | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTER | September 1, 2009 |
| K062659 | kirwan surgical products | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | March 9, 2007 |
| K023506 | modern medical equipment mfg | SURGICAL MEDICAL DEVICE CAUTERY | January 13, 2004 |
| K002547 | starion instruments | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | October 20, 2000 |
| K994019 | starion instruments | CAUTERY GRASPER/DISSECTOR | January 20, 2000 |
| K990728 | starion instruments | THERMAL CAUTERY DEVICE, FORCEPS | June 3, 1999 |
| K952784 | oxboro medical intl | OXBORO-MEDICAL CAUTERY TIP CLEANER | July 13, 1995 |
| K945761 | aaron medical industries | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | April 10, 1995 |
| K945763 | aaron medical industries | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP | February 7, 1995 |
| K945762 | aaron medical industries | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE | February 7, 1995 |
| K945493 | aaron medical industries | OPHTHALMIC CAUTERY | January 30, 1995 |
| K933079 | pmt | ELECTROCAUTERY SYSTEM MODEL 1980 | February 22, 1994 |
| K875260 | effner and spreine | EFFNER CAUTERY INSTRUMENTS | June 6, 1988 |
| K841325 | suncoast medical manufacturers | REPLACE-A-TIP RECHARG. LOW TEMP. | May 9, 1984 |
| K840425 | suncoast medical manufacturers | OPTHERM FINE TIP | May 9, 1984 |
| K841326 | suncoast medical manufacturers | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | May 9, 1984 |
| K840426 | suncoast medical manufacturers | OPTHERM EXTRA FINE TIP | May 9, 1984 |
| K820157 | xomed | XOMED THERMAL MYRINGOTOMY SYSTEM | March 2, 1982 |
| K810012 | medical products development | MULTIMICRO SURGICAL CAUTERY | April 23, 1981 |