FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYSTEROSCOPIC MYOMA SCREW
K Number: K915412
·
Decision May 18, 1992
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
104
Review Days
168
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Basic Information
- Device Name
- HYSTEROSCOPIC MYOMA SCREW
- K Number
- K915412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cook Urological, Inc.
- Date Received
- December 2, 1991
- Decision Date
- May 18, 1992
- Product Code
- HHO
- 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 |
|---|---|---|---|
| HHO | Screw, Fibroid, Gynecological | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHO), ordered by most recent decision date.
View allOther Clearances by Cook Urological, Inc.
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| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |