FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
GLOVE-N-GEL AMNIOTOMY KIT
K Number: K910518
·
Decision May 9, 1991
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
5
Applicant Total
13
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GLOVE-N-GEL AMNIOTOMY KIT
- K Number
- K910518
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Epcom Medical Systems, Inc.
- Date Received
- February 6, 1991
- Decision Date
- May 9, 1991
- Product Code
- HGE
- 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 |
|---|---|---|---|
| HGE | Amniotome | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGE), ordered by most recent decision date.
OBSTI-HOOK
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
AMNIPERF(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
S.C.M.T. PERFORATOR
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
AMNIGLOVE & AMNICOT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
H.R. JAKOBI SURG. INSTRUMENTS #4 30/31
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Epcom Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905812 | INTRAUTERINE CATHETER SET | Jan 31, 1991 | Substantially Equivalent |
| K881414 | CERVICATH | Jun 14, 1988 | Substantially Equivalent |
| K871079 | FETALFLEX FETAL ELECTRODE | Jul 13, 1987 | Substantially Equivalent |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | Feb 25, 1985 | Substantially Equivalent |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | Jan 2, 1985 | Substantially Equivalent |
| K841805 | OBSTETRICAL DOPPLER | Jun 19, 1984 | Substantially Equivalent |
| K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE | Aug 12, 1983 | Substantially Equivalent |
| K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR | Aug 12, 1983 | Substantially Equivalent |
| K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET | Aug 12, 1983 | Substantially Equivalent |
| K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE | Jun 30, 1983 | Substantially Equivalent |