Product code HQP
- Device name
- Unit, Cautery, Thermal, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4115
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Bovie Medical Corporation | 2012-07-20 |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Fiab Spa | 2009-09-01 |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | Kirwan Surgical Products, Inc. | 2007-03-09 |
| K023506 | SURGICAL MEDICAL DEVICE CAUTERY | Modern Medical Equipment Mfg., Ltd. | 2004-01-13 |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | Starion Instruments | 2000-10-20 |
| K994019 | CAUTERY GRASPER/DISSECTOR | Starion Instruments | 2000-01-20 |
| K990728 | THERMAL CAUTERY DEVICE, FORCEPS | Starion Instruments | 1999-06-03 |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Oxboro Medical Intl., Inc. | 1995-07-13 |
| K945761 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP | Aaron Medical Industries | 1995-04-10 |
| K945763 | LOW TEMPERATURE CAUTERY ELONGATED FINE TIP | Aaron Medical Industries | 1995-02-07 |
| K945762 | LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE | Aaron Medical Industries | 1995-02-07 |
| K945493 | OPHTHALMIC CAUTERY | Aaron Medical Industries | 1995-01-30 |
| K933079 | ELECTROCAUTERY SYSTEM MODEL 1980 | Pmt Corp. | 1994-02-22 |
| K875260 | EFFNER CAUTERY INSTRUMENTS | Effner and Spreine Co. | 1988-06-06 |
| K840425 | OPTHERM FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
| K840426 | OPTHERM EXTRA FINE TIP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
| K841325 | REPLACE-A-TIP RECHARG. LOW TEMP. | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
| K841326 | REPLACE-A-TIP RECHARGEABLE HIGH TEMP | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
| K820157 | XOMED THERMAL MYRINGOTOMY SYSTEM | Xomed, Inc. | 1982-03-02 |
| K810012 | MULTIMICRO SURGICAL CAUTERY | Medical Products Development, Inc. | 1981-04-23 |
| K810016 | REPLACABLE BATTERY PERFECTEMP CAUTERY | Medical Products Development, Inc. | 1981-04-23 |
| K810013 | MULTIPERFECTEMP CAUTERY | Medical Products Development, Inc. | 1981-04-23 |
| K801078 | PERFECTEMP OPHTHALMIC CAUTERY | Medical Products Development, Inc. | 1980-06-04 |
| K771189 | HOT TEMP CAUTERY | Edward Weck, Inc. | 1977-07-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10887482177508 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177423 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482175160 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177119 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177133 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177157 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177171 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177201 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177225 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177249 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177263 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177287 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177409 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 30886158010198 | Accu-temp® | Beaver-Visitec International, Inc. | 2022-01-19 |
| 30886158010181 | Accu-temp® | Beaver-Visitec International, Inc. | 2022-01-19 |
| 30886158010235 | Accu-temp | Beaver-Visitec International, Inc. | 2022-01-19 |
| 00385640053709 | SUMMIT MEDICAL | Summit Medical, Inc. | 2021-04-15 |
| M220P2120005 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 10612479209098 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 00607151008956 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00607151008987 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00607151008994 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00607151009007 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00607151011000 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00607151011024 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-11 |
| 00304040007297 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040007303 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040007310 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10885632103179 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-29 |
| 10885632103162 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-29 |