FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEDLACEK HANDLE
K Number: K926179
·
Decision Mar 25, 1994
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
12
Review Days
472
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Basic Information
- Device Name
- SEDLACEK HANDLE
- K Number
- K926179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Simpson/Basye, Inc.
- Date Received
- December 8, 1992
- Decision Date
- March 25, 1994
- Product Code
- HGI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Simpson/Basye, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891352 | MARLOW ANAL SPECULUM | Jun 23, 1989 | Substantially Equivalent |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent |
| K891347 | REID ENDOCERVICAL SPREADER | Mar 29, 1989 | Substantially Equivalent |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Mar 29, 1989 | Substantially Equivalent |
| K891349 | CAMPION CERVICAL HOOK | Mar 29, 1989 | Substantially Equivalent |
| K891348 | CAMPION LASER FORCEPS | Mar 22, 1989 | Substantially Equivalent |
| K870276 | HEATED INSTRUMENT BATH | May 7, 1987 | Substantially Equivalent |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Jun 22, 1979 | Substantially Equivalent |