FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O'NEIL URINARY CATHETER INTRODUCER
K Number: K884819
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
63
Applicant Total
11
Review Days
92
Basic Information
- Device Name
- O'NEIL URINARY CATHETER INTRODUCER
- K Number
- K884819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL MARKETING GROUP
- Date Received
- November 17, 1988
- Decision Date
- February 17, 1989
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by MEDICAL MARKETING GROUP
| K Number | Device Name | ||
|---|---|---|---|
| K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT | Apr 2, 1991 | Unknown |
| K874682 | MMG CATHETER PLUG W/DRAINAGE TUBE COVER | Jan 27, 1988 | Substantially Equivalent |
| K871999 | MMG URO-SELF CATHETER | Aug 25, 1987 | Substantially Equivalent |
| K863912 | THE MMG 5 IN 1 CONNECTOR | Oct 27, 1986 | Substantially Equivalent |
| K840838 | MMG CONNECTIVE TUBING | Mar 30, 1984 | Substantially Equivalent |
| K821168 | DISPOSABLE URINARY LEGBAG W/STRAP | May 24, 1982 | Substantially Equivalent |
| K811469 | MMG URINARY DRAINAGE TUBING | Jun 12, 1981 | Substantially Equivalent |
| K800694 | MMG DISPOSABLE URINARY LEG BAG | May 30, 1980 | Substantially Equivalent |
| K791847 | ASPRI-LUKE | Oct 2, 1979 | Substantially Equivalent |
| K790279 | CATHETER, MMG LATEX EXTERNAL | Mar 6, 1979 | Substantially Equivalent |