FDA Product Code
FDA Product Code HQR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4100
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050308 | THERMAL CAUTERY PROBE | Starion Instruments | 2005-02-25 | Special | PDF ↗ |
| K990064 | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | Ophthalmic Technologies, Inc. | 1999-04-04 | Traditional | PDF ↗ |
| K980522 | REFRACTEC MCS-100 | Refractec, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | 1998-03-13 | Traditional | PDF ↗ |
| K952151 | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | Storz | 1996-03-04 | Traditional | PDF ↗ |
| K955158 | SURGITRON | Ellman Intl., Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | 1996-01-05 | Traditional | PDF ↗ |
| K941495 | RETURN PATH DIATHERMY HANDLE | Mira, Inc. | 1994-07-15 | Traditional | PDF ↗ |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Mentor O & O, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Advanced Surgical Products, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | United Surgical Corp. | 1987-02-20 | Traditional | PDF ↗ |
Product code HQR · Class II · Ophthalmic. Data: openFDA.