Set, Anesthesia, Paracervical
The Paracervical Anesthesia Set is a kit used to administer local anesthetic agents near the cervix to block pain transmission from the uterus during obstetric or gynecological procedures such as dilation and curettage or childbirth. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEE, regulated under 21 CFR 884.5100, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HEE
- Device Class
- FDA class 2
- Regulation Number
- 884.5100
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Oct 17, 2005 | Substantially Equivalent | Rocket Medical Plc |
| K021224 | ENDOCERVICAL BLOCK NEEDLE | Jul 12, 2002 | Substantially Equivalent | Wallach Surgical Devices, Inc. |
| K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | Apr 13, 2000 | Substantially Equivalent | Avid Medical, Inc. |
| K983897 | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G | Feb 01, 1999 | Substantially Equivalent | Ri Mos. S.R.L. |
| K980238 | GYNEX EXTENDED REACH NEEDLE | Aug 21, 1998 | Substantially Equivalent | Gynex Corp. |
| K973671 | ENDOCERVICAL BLOCK NEEDLE | Nov 26, 1997 | Substantially Equivalent | A & A Medical, Inc. |
| K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE | Feb 29, 1996 | Substantially Equivalent | Ellman Intl., Inc. |
| K910253 | LEEP REDIKIT | Apr 18, 1991 | Substantially Equivalent | CooperSurgical, Inc. |
| K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE | Mar 04, 1991 | Substantially Equivalent | CooperSurgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.