FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GORSK INSTRUMENT REST
K Number: K873554
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
2
Review Days
56
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
- GORSK INSTRUMENT REST
- K Number
- K873554
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Gorsk, Inc.
- Date Received
- August 28, 1987
- Decision Date
- October 23, 1987
- Product Code
- HMG
- 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 |
|---|---|---|---|
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMG), ordered by most recent decision date.
A-SCAN ROLL-AROUND STAND
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC TABLE
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Gorsk, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Oct 23, 1987 | Substantially Equivalent |