Product code HQR— Ophthalmic
ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
- Classification name
- Apparatus, Cautery, Radiofrequency, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.4100
- Advisory panel
- Ophthalmic
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HQR
FDA has cleared devices under product code HQR between 1987 and 2005, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 1999
- 1998
- 1996
- 1994
- 1990
- 1987
Top applicants under product code HQR
Recent clearances under product code HQR
- K050308 — THERMAL CAUTERY PROBE
- K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
- K980522 — REFRACTEC MCS-100
- K972749 — PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
- K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
- K955158 — SURGITRON
- K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
- K941495 — RETURN PATH DIATHERMY HANDLE
- K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
- K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
- K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.