STERILE OIL AND GUIDEWIRE
FDA 510(k) clearance K833671 · decided 1984-01-10
Clearance details
- K-number
- K833671
- Device name
- STERILE OIL AND GUIDEWIRE
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-18
- Decision date
- 1984-01-10
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HNL
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Southampton, GB
- 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 |
|---|---|---|
| CONCEPT FIBER OPTIC CANALICULUS INTUBA (K843491) | Concept, Inc. | 1984-10-05 |
| TSE-ANDERSON MODIFIED LACRIMAL GROOV (K840861) | Hansen Ophthalmic Development Lab | 1984-05-09 |
| LACIMAL INTUBATION SETS (K831901) | Visitec Co. | 1983-07-12 |
| PILLING LACRIMAL INTUBATION SYSTEM (K813187) | Narco Scientific | 1982-01-28 |
| ETHICON LACRIMAL STENT (K812255) | ETHICON, Inc. | 1981-08-20 |
| CONCEPT CANALICULUS INTUBATION SET (K802845) | Concept, Inc. | 1980-12-17 |
| JACKSON LACRIMAL INTUBATION SET (K801232) | Storz Instrument Co. | 1980-06-17 |
| CRAWFORD LACRIMAL INTUBATION SET (K800089) | Jedmed Instrument Co. | 1980-03-03 |
| NASO-LACRIMAL DUCT INSERT (K770194) | Concept, Inc. | 1977-02-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |