FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNASPYR VACUUM CURETTAGE UNIT
K Number: K850312
·
Decision Feb 28, 1985
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
24
Review Days
34
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Basic Information
- Device Name
- GYNASPYR VACUUM CURETTAGE UNIT
- K Number
- K850312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- January 25, 1985
- Decision Date
- February 28, 1985
- Product Code
- HHI
- 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 |
|---|---|---|---|
| HHI | System, Abortion, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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CANNULA, SUCTION UTERINE
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| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | Nov 17, 1987 | Substantially Equivalent |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |