HEE · Set, Anesthesia, Paracervical
Obstetrics/Gynecology · 21 CFR 884.5100 · Class 2
Overview
| Product Code | HEE |
|---|---|
| Device Name | Set, Anesthesia, Paracervical |
| Regulation | 21 CFR 884.5100 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Rocket Medical Plc | Oct 17, 2005 | SESE |
| K021224 | ENDOCERVICAL BLOCK NEEDLE | Wallach Surgical Devices, Inc. | Jul 12, 2002 | SESE |
| K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | Avid Medical, Inc. | Apr 13, 2000 | SESE |
| K983897 | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G | Ri Mos. S.R.L. | Feb 1, 1999 | SESE |
| K980238 | GYNEX EXTENDED REACH NEEDLE | Gynex Corp. | Aug 21, 1998 | SESE |
| K973671 | ENDOCERVICAL BLOCK NEEDLE | A & A Medical, Inc. | Nov 26, 1997 | SESE |
| K954718 | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE | Ellman Intl., Inc. | Feb 29, 1996 | SESE |
| K910253 | LEEP REDIKIT | CooperSurgical, Inc. | Apr 18, 1991 | SESE |
| K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE | CooperSurgical, Inc. | Mar 4, 1991 | SESE |
Top Applicants
- CooperSurgical, Inc. — 2 clearances
- A & A Medical, Inc. — 1 clearance
- Avid Medical, Inc. — 1 clearance
- Ellman Intl., Inc. — 1 clearance
- Gynex Corp. — 1 clearance
