FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGITEL
K Number: K934494
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
2
Applicant Total
1
Review Days
132
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Basic Information
- Device Name
- SURGITEL
- K Number
- K934494
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4770
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- General Scientific Corp.
- Date Received
- September 15, 1993
- Decision Date
- January 25, 1994
- Product Code
- HOH
- 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 |
|---|---|---|---|
| HOH | Spectacle, Operating (Loupe), Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOH), ordered by most recent decision date.
LOW-POWER BINOCULAR LOUPE
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EXETER OPERATING LOUPE
FDA 510(k)
FDA Class 1
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