EYE DRAPE
FDA 510(k) clearance K830822 · decided 1983-04-06
Clearance details
- K-number
- K830822
- Device name
- EYE DRAPE
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-15
- Decision date
- 1983-04-06
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- HMT
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (K945738) | Visitec Co. | 1995-02-14 |
| STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (K905460) | Angiosystems, Inc. | 1991-02-06 |
| SOLOS EYESITE DRAPES (K872620) | Solos Ophthalmology | 1987-07-31 |
| OPTHA PREP (K871706) | Treace Medical, Inc. | 1987-05-18 |
| SURGICAL DRAPES, OPHTHALMIN (K854613) | Charles Atkins & Co. | 1986-02-13 |
| DRAIN-R-DRAPE(EYE (K831340) | Sur-Tech, Inc. | 1983-06-08 |
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 |