FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMNIO CENTESES KIT W/NEEDLE
K Number: K830019
·
Decision Jan 18, 1983
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
21
Review Days
14
Basic Information
- Device Name
- AMNIO CENTESES KIT W/NEEDLE
- K Number
- K830019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- UNIVERSAL MEDICAL INSTRUMENT CORP.
- Date Received
- January 4, 1983
- Decision Date
- January 18, 1983
- Product Code
- HIO
- 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 |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIO), ordered by most recent decision date.
G.E. STERILE AMNIOCENTESIS TRAY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
AMNIOTEST(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SONO-VU US(TM), MODIFICATION
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by UNIVERSAL MEDICAL INSTRUMENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K962180 | CATH SEAL | Nov 7, 1996 | Substantially Equivalent |
| K935077 | CATH-SEAL | Jun 7, 1994 | Substantially Equivalent |
| K897128 | UMI BRAIDED CATHETER CONNECTOR | Mar 1, 1990 | Substantially Equivalent |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Jul 26, 1988 | Substantially Equivalent |
| K863178 | UMI STEERABLE TORQUE GUIDE WIRE | Sep 19, 1986 | Substantially Equivalent |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | Aug 5, 1986 | Substantially Equivalent |
| K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE | Feb 19, 1986 | Substantially Equivalent |
| K851088 | UMI ANGIOGRAPHIC CATHETER | May 16, 1985 | Substantially Equivalent |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | Apr 10, 1985 | Substantially Equivalent |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Jan 31, 1985 | Substantially Equivalent |