FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700
K Number: K880337
·
Decision Apr 14, 1988
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
29
Applicant Total
16
Review Days
79
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
- MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700
- K Number
- K880337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Plasco, Inc.
- Date Received
- January 26, 1988
- Decision Date
- April 14, 1988
- Product Code
- FCE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCE | Enema Kit | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCE), ordered by most recent decision date.
AMSURE CLEANSING ENEMA SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PRO-FLO SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
4 SURE TM ENEMA BAG SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ENEMA KIT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ENEMA BULB
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ENEMA BAG SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Plasco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980066 | CPR FILTERSHIELD | Jul 16, 1998 | Substantially Equivalent |
| K953414 | CPR MICROMASK WITH OXYGEN INLET | Mar 20, 1996 | Substantially Equivalent |
| K951483 | CPR MICROMASK | Oct 19, 1995 | Substantially Equivalent |
| K950769 | CPR MICROMASK PLUS CATALOG NO 73-402 | Mar 10, 1995 | Substantially Equivalent |
| K950770 | CPR MICROSHIELD II | Mar 10, 1995 | Substantially Equivalent |
| K943386 | CPR MICROMASK | Feb 21, 1995 | Substantially Equivalent |
| K932649 | PHARMAFEED | Nov 16, 1993 | Substantially Equivalent |
| K870623 | ENTERAL ADMINISTRATION SET | Jun 26, 1987 | Substantially Equivalent |
| K870019 | THE LAHR BALLOON | Apr 1, 1987 | Substantially Equivalent |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Apr 1, 1987 | Substantially Equivalent |