FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LENS INSERTION GLIDE
K Number: K840694
·
Decision May 9, 1984
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
12
Review Days
83
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
- LENS INSERTION GLIDE
- K Number
- K840694
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Innovative Surgical Products, Inc.
- Date Received
- February 16, 1984
- Decision Date
- May 9, 1984
- Product Code
- KYB
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYB), ordered by most recent decision date.
MicroSTAAR Injector System Cartridges
FDA 510(k)
FDA Class 1
·Ophthalmic
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
FDA 510(k)
FDA Class 1
·Ophthalmic
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
FDA 510(k)
FDA Class 1
·Ophthalmic
IOL INJECTOR SET
FDA 510(k)
FDA Class 1
·Ophthalmic
MONARCH III IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Innovative Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843041 | HESLIN DISPOS. TUBING SET | Nov 21, 1984 | Substantially Equivalent |
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | May 22, 1984 | Substantially Equivalent |
| K840695 | PHACOEMULSIFICATION KITS | May 22, 1984 | Substantially Equivalent |
| K841072 | IRRIGATION, ASPIRATION TUBING SETS | Mar 29, 1984 | Substantially Equivalent |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | Sep 29, 1983 | Substantially Equivalent |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Jun 22, 1982 | Substantially Equivalent |
| K820765 | PLEURAL DRAINAGE RESERVOIR | Apr 15, 1982 | Substantially Equivalent |
| K820680 | DISPOSABLE TUBING SETS | Apr 9, 1982 | Substantially Equivalent |
| K802973 | ISPVAC TM | Dec 19, 1980 | Substantially Equivalent |
| K801350 | ACUVAC(TM) SUCTION RESERVOIR 400CC AND | Jul 14, 1980 | Substantially Equivalent |