FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STEPHENS DISPOSABLE FORCEPS
K Number: K022835
·
Decision Nov 1, 2002
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
5
Review Days
66
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Basic Information
- Device Name
- STEPHENS DISPOSABLE FORCEPS
- K Number
- K022835
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stephens Instruments
- Date Received
- August 27, 2002
- Decision Date
- November 1, 2002
- Product Code
- HNR
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Stephens Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K022840 | STEPHENS DISPOSABLE SCISSORS | Nov 1, 2002 | Substantially Equivalent |
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Nov 1, 2002 | Substantially Equivalent |
| K022836 | STEPHENS DISPOSABLE SPECULUM | Nov 1, 2002 | Substantially Equivalent |
| K022842 | STEPHENS DISPOSABLE HOOKS | Nov 1, 2002 | Substantially Equivalent |