DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
FDA 510(k) clearance K990064 · decided 1999-04-04
Clearance details
- K-number
- K990064
- Device name
- DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
- Applicant
- Ophthalmic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-08
- Decision date
- 1999-04-04
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HQR
- Device class
- 2
- Regulation number
- 886.4100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Downsview, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMAL CAUTERY PROBE (K050308) | Starion Instruments | 2005-02-25 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.