HGE — Amniotome Class I
FDA Device Classification
Classification Details
- Product Code
- HGE
- Device Class
- Class I
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K951148 | onli | OBSTI-HOOK | June 9, 1995 |
| K926425 | raymart development | AMNIPERF(TM) | March 7, 1994 |
| K910518 | epcom medical systems | GLOVE-N-GEL AMNIOTOMY KIT | May 9, 1991 |
| K871087 | salt creek medical technologies | S.C.M.T. PERFORATOR | March 23, 1987 |
| K850758 | go medical industries pty. | AMNIGLOVE & AMNICOT | April 15, 1985 |
| K834177 | imm enterprises | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | December 27, 1983 |