Product code HQR
- Device name
- Apparatus, Cautery, Radiofrequency, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4100
- 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 |
|---|---|---|---|
| K050308 | THERMAL CAUTERY PROBE | Starion Instruments | 2005-02-25 |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | 1999-04-04 |
| K980522 | REFRACTEC MCS-100 | Refractec, Inc. | 1998-07-22 |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | 1998-03-13 |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Storz | 1996-03-04 |
| K955158 | SURGITRON | Ellman Intl., Inc. | 1996-02-09 |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | 1996-01-05 |
| K941495 | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | 1994-07-15 |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Mentor O & O, Inc. | 1994-02-16 |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Advanced Surgical Products, Inc. | 1990-01-22 |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | United Surgical Corp. | 1987-02-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00757770636280 | Bausch + Lomb | Bausch & Lomb Incorporated | 2025-11-14 |
| 00757770430772 | Bausch + Lomb | Bausch & Lomb Incorporated | 2024-11-21 |
| 04049539100498 | DIATHERMY BIPOLAR CABLE | Carl Zeiss Meditec AG | 2022-04-25 |
| 04049539100504 | DIATHERMY FORCEPS | Carl Zeiss Meditec AG | 2022-04-25 |
| 00757770423606 | Bausch + Lomb | Bausch & Lomb Incorporated | 2021-05-10 |
| 00781096117260 | Ducks Unlimited | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096117253 | Ducks Unlimited | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096117277 | Ducks Unlimited | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096117284 | Ducks Unlimited | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096117307 | Ducks Unlimited | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096207206 | Trina Turk | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00781096207213 | Trina Turk | MCGEE GROUP, INC., THE | 2019-10-04 |
| 00380651283015 | Alcon | Alcon Laboratories, Inc. | 2018-10-26 |
| 00380651295018 | Alcon | Alcon Laboratories, Inc. | 2017-08-22 |
| 00757770416974 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770428786 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770425532 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770421251 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770411269 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770410576 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770409617 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770409167 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770408238 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770407842 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770406579 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770404582 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770403059 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00757770402793 | Bausch + Lomb | Bausch & Lomb Incorporated | 2016-09-24 |
| 00380651293014 | Alcon | Alcon Laboratories, Inc. | 2016-09-24 |
| 00380651291010 | Alcon | Alcon Laboratories, Inc. | 2016-09-24 |