CLEARCUT S SAFETY KNIFE
FDA 510(k) clearance K110166 · decided 2011-05-20
Clearance details
- K-number
- K110166
- Device name
- CLEARCUT S SAFETY KNIFE
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-20
- Decision date
- 2011-05-20
- Days to decision
- 120 days
- Clearance type
- Abbreviated
- Product code
- HNN
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alcon Research
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| SAPPHIRE KNIFE BLADE (K861744) | Keeler Instruments, Inc. | 1986-06-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Desc recall (Z-1922-2024) | Alcon Research LLC | 2024-05-30 |
| ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software recall (Z-1923-2024) | Alcon Research LLC | 2024-05-30 |
| ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Softwar recall (Z-1924-2024) | Alcon Research LLC | 2024-05-30 |
| ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Softwar recall (Z-1925-2024) | Alcon Research LLC | 2024-05-30 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115) | Alcon Research, Ltd. | 2025-08-25 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S068) | Alcon Research, Ltd. | 2025-07-25 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111) | Alcon Research, Ltd. | 2025-06-18 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S067) | Alcon Research, Ltd. | 2025-02-26 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |