FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K Number: K844558
·
Decision Jan 31, 1985
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
19
Applicant Total
21
Review Days
71
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Basic Information
- Device Name
- UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
- K Number
- K844558
- 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
- November 21, 1984
- Decision Date
- January 31, 1985
- 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.
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VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
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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 |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | Aug 1, 1984 | Substantially Equivalent |