FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
pioli IOL Delivery System
K Number: K172228
·
Decision Dec 15, 2017
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
62
Applicant Total
4
Review Days
143
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
- pioli IOL Delivery System
- K Number
- K172228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ast Products, Inc.
- Date Received
- July 25, 2017
- Decision Date
- December 15, 2017
- Product Code
- MSS
- 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 |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSS), ordered by most recent decision date.
RxSight® Insertion Device
FDA 510(k)
FDA Class 1
·Ophthalmic
ACCUJECT Injector Set 2.1-1P (LP604590)
FDA 510(k)
FDA Class 1
·Ophthalmic
EyeGility Inserter for Preloaded enVista IOLs
FDA 510(k)
FDA Class 1
·Ophthalmic
Accuject Refra Injector AR2900
FDA 510(k)
FDA Class 1
·Ophthalmic
RxSight® Insertion Device (63002)
FDA 510(k)
FDA Class 1
·Ophthalmic
RxSight Insertion Device
FDA 510(k)
FDA Class 1
·Ophthalmic