FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MMG FOLEY CATHETER
K Number: K840839
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
12
Review Days
53
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
- MMG FOLEY CATHETER
- K Number
- K840839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Technologies of Georgia
- Date Received
- February 24, 1984
- Decision Date
- April 17, 1984
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOD), ordered by most recent decision date.
Rubber Utility Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Wellead Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
allFlex Ureteral Catheters, Krait Ureteral Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UroGen Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medical Technologies of Georgia
| K Number | Device Name | ||
|---|---|---|---|
| K973120 | READYCATH CATHETER | Feb 25, 1998 | Substantially Equivalent |
| K952392 | MLI SET | Aug 7, 1995 | Substantially Equivalent |
| K911129 | MMG BILE BAG | Aug 7, 1991 | Substantially Equivalent |
| K873136 | MMG CATH-N-PLACE | Sep 9, 1987 | Substantially Equivalent |
| K871949 | MMG DELEE SUCTION CATHETER W/MUCOUS TRAP | Jun 15, 1987 | Substantially Equivalent |
| K854821 | MMG EXTERNAL FEMALE CATHETERS | Apr 24, 1986 | Substantially Equivalent |
| K854660 | THE MMG ENTERAL FEEDING ADMINISTRATION SET | Jan 21, 1986 | Substantially Equivalent |
| K840897 | OXYGEN TUBING | Mar 16, 1984 | Substantially Equivalent |
| K821854 | U-200 BAG | Jul 22, 1982 | Substantially Equivalent |
| K821853 | U-100 BAG | Jul 22, 1982 | Substantially Equivalent |