FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOI(TM) INSTRUMENT TRAYS
K Number: K881095
·
Decision Apr 6, 1988
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
97
Review Days
22
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KOI(TM) INSTRUMENT TRAYS
- K Number
- K881095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- March 15, 1988
- Decision Date
- April 6, 1988
- Product Code
- LRP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRP), ordered by most recent decision date.
LACERATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EYE TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUSTOM ENT PACKS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORTHOPEDIC TRAY PRODUCT LINE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GENERAL SURGERY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by CooperVision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | Jan 25, 2024 | Substantially Equivalent |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | Feb 4, 2022 | Substantially Equivalent |
| K213164 | Avaira Vitality | Oct 26, 2021 | Substantially Equivalent |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | Oct 20, 2020 | Substantially Equivalent |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | Mar 23, 2020 | Substantially Equivalent |
| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |