MICROSURGERY KNIFE
FDA 510(k) clearance K820618 · decided 1982-04-09
Clearance details
- K-number
- K820618
- Device name
- MICROSURGERY KNIFE
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-08
- Decision date
- 1982-04-09
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- HNN
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| CLEARCUT S SAFETY KNIFE (K110166) | Alcon Research, Ltd. | 2011-05-20 |
| OPHTHALMIC KNIFE (K922378) | Microptics Development Laboratory | 1992-12-10 |
| RETRACTIVE INCISION MICROMETER (RIM) GUAGE (K882402) | Optical Center | 1988-08-22 |
| MVR/STILETTO BLADE 20GA. - P/N 1900 (K881669) | Advanced Surgical Products, Inc. | 1988-05-13 |
| PRISMA DISPOSABLE MVR/STILETTO BLADE (K874979) | Advanced Surgical Products, Inc. | 1988-04-13 |
| OPHTHALMIC TIP & BLADE SCALPELS (K874057) | Myocure, Inc. | 1987-12-23 |
| OPHTHALMIC DISPOSABLE BLADES (K874056) | Myocure, Inc. | 1987-12-22 |
| OPHTHALMIC PHACO-BLADE (K873385) | Myocure, Inc. | 1987-09-21 |
| KNIFE, OPHTHALMIC (K871285) | Trueline Instruments, Inc. | 1987-04-27 |
| RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (K864290) | Keeler Instruments, Inc. | 1986-12-15 |
| CATARACT DIAMOND KNIFE (K863725) | Medical Technology Development Corp. | 1986-10-31 |
| THE ULTIMATE (K863665) | Myocure, Inc. | 1986-09-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240 recall (Z-1344-04) | BD Opthalmic Systems | 2004-08-14 |