KOI(TM) INSTRUMENT TRAYS
FDA 510(k) clearance K881095 · decided 1988-04-06
Clearance details
- K-number
- K881095
- Device name
- KOI(TM) INSTRUMENT TRAYS
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-15
- Decision date
- 1988-04-06
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LRP
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bellevue, WA, 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 |
|---|---|---|
| LACERATION TRAY (K963723) | Grand Medical Products | 1996-11-27 |
| OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (K951811) | Osteotech, Inc. | 1995-05-31 |
| EYE TRAY (K940239) | Cush Medical Products | 1994-06-28 |
| CUSTOM ENT PACKS (K935621) | Associated Medical | 1994-03-30 |
| ORTHOPEDIC TRAY PRODUCT LINE (K940646) | Cushindu | 1994-03-11 |
| GENERAL SURGERY TRAY (K940444) | Cush Medical Products | 1994-03-07 |
| HOSPITAL KIT ENT 1125 (K922126) | Savoy Medical Supply Co., Inc. | 1993-01-21 |
| EYE TRAY (K912105) | Medical Device Inspection Co., Inc. | 1991-08-29 |
| KITS AND TRAYS FOR ONE TIME USE ONLY (K903963) | Apk Technology | 1991-07-29 |
| INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (K903962) | Apk Technology | 1991-07-29 |
| PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (K905462) | Angiosystems, Inc. | 1991-02-06 |
| CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (K903544) | J.J. Skinner, Inc. | 1990-08-31 |
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 |