HQR
11 FDA 510(k) clearances · Product code
116 daysmedian time to decision
233 days90th percentile
11clearances measured
FDA profile
- Official device name
- Apparatus, Cautery, Radiofrequency, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4100
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1993: 1 · 1994: 1 · 1995: 1 · 1997: 1 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THERMAL CAUTERY PROBE (K050308) | Starion Instruments | 2005-02-25 |
| DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (K990064) | Ophthalmic Technologies, Inc. | 1999-04-04 |
| REFRACTEC MCS-100 (K980522) | Refractec, Inc. | 1998-07-22 |
| PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) (K972749) | C.M. Chance , Ltd. | 1998-03-13 |
| STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) (K952151) | Storz | 1996-03-04 |
| SURGITRON (K955158) | Ellman Intl., Inc. | 1996-02-09 |
| GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (K952569) | Gamp & Assoc. | 1996-01-05 |
| RETURN PATH DIATHERMY HANDLE (K941495) | Mira, Inc. | 1994-07-15 |
| MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION (K934320) | Mentor O & O, Inc. | 1994-02-16 |
| ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (K895800) | Advanced Surgical Products, Inc. | 1990-01-22 |
| UNITED SURGICAL CORP. DIATHERMIC PLUS (K870194) | United Surgical Corp. | 1987-02-20 |
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Every clearance here is in the API, with alerts when new ones post.