MICRO-MITT
FDA 510(k) clearance K830821 · decided 1983-04-27
Clearance details
- K-number
- K830821
- Device name
- MICRO-MITT
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-15
- Decision date
- 1983-04-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FXP
- Device class
- 1
- Regulation number
- 878.4040
- 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 |
|---|---|---|
| PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076) | Primeline Medical Products, Inc. | 1998-01-13 |
| FAR-EAST SHOE COVERS (K971191) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| CONVERTORS IMPERVIOUS SHOE COVERS (K970815) | Allegiance Healthcare Corp. | 1997-03-27 |
| SHOE COVER, NON-STERILE (K961342) | Copioumed Intl., Inc. | 1996-12-30 |
| FLUID BARRIER BOOT KNEE & ANKLE-HIGH (K955835) | Instrument Makar, Inc. | 1996-11-19 |
| NIOMED NON-SKID SHOE COVERS (K952937) | Amerasia Corp. | 1995-10-23 |
| NIOMED SHOE COVERS (K952897) | Amerasia Corp. | 1995-10-23 |
| OREX SHOE COVERS (K943034) | Thantex Specialties, Inc. | 1995-01-02 |
| KAPPLER PRO/VENT BOOT (K932738) | Kappler, Inc. | 1994-03-29 |
| REUSABLE LIQUIDPROOF BOOTIE (K925815) | Amsco Sterile Recoveries, Inc. | 1993-07-09 |
| STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (K914702) | Depuy, Inc. | 1993-01-29 |
| DISPOSABLE SHOE COVER (K913628) | Gem Nonwovews, Inc. | 1991-10-04 |
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 |