FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
K Number: K983897
·
Decision Feb 1, 1999
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
8
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
- K Number
- K983897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ri Mos. S.R.L.
- Date Received
- November 3, 1998
- Decision Date
- February 1, 1999
- Product Code
- HEE
- 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 |
|---|---|---|---|
| HEE | Set, Anesthesia, Paracervical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEE), ordered by most recent decision date.
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
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ENDOCERVICAL BLOCK NEEDLE
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AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
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GYNEX EXTENDED REACH NEEDLE
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ENDOCERVICAL BLOCK NEEDLE
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ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Ri Mos. S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K992926 | GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) | Oct 26, 1999 | Substantially Equivalent |
| K991895 | RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) | Aug 12, 1999 | Substantially Equivalent |
| K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 | Jul 19, 1999 | Substantially Equivalent |