Amniotome
The Amniotome is a thin, hook-like instrument used to artificially rupture the amniotic membranes (amniotomy) during labor to stimulate or accelerate uterine contractions or allow access for intrauterine monitoring. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HGE, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. No special risk flags apply.
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Basic Information
- Product Code
- HGE
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951148 | OBSTI-HOOK | Jun 09, 1995 | Substantially Equivalent | Onli |
| K926425 | AMNIPERF(TM) | Mar 07, 1994 | Substantially Equivalent | Raymart Development Co. |
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | May 09, 1991 | Unknown | Epcom Medical Systems, Inc. |
| K871087 | S.C.M.T. PERFORATOR | Mar 23, 1987 | Substantially Equivalent | Salt Creek Medical Technologies |
| K850758 | AMNIGLOVE & AMNICOT | Apr 15, 1985 | Substantially Equivalent | Go Medical Industries Pty. , Ltd. |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | Dec 27, 1983 | Substantially Equivalent | Imm Enterprises , Ltd. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.