FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED FOLEY CATHETER
K Number: K863302
·
Decision Oct 3, 1986
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
39
Review Days
39
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
- MODIFIED FOLEY CATHETER
- K Number
- K863302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sheridan Catheter Corp.
- Date Received
- August 25, 1986
- Decision Date
- October 3, 1986
- 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 Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922894 | LAZER-TRACH TRACHEAL TUBE | May 7, 1993 | Substantially Equivalent |
| K897046 | LASER RESISTANT TRACHEAL TUBE | Mar 23, 1990 | Substantially Equivalent |
| K890823 | ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER | May 5, 1989 | Substantially Equivalent |
| K884765 | CLINICAL ELECTRONIC THERMOMETERS | Feb 16, 1989 | Substantially Equivalent |
| K882918 | KIM NASO-INTESTINAL TUBE | Dec 5, 1988 | Substantially Equivalent |
| K882127 | CLINICAL ELECTRONIC THERMOMETERS | Aug 4, 1988 | Substantially Equivalent |
| K881368 | CLINICAL ELECTONIC THERMOMETERS | Jul 13, 1988 | Substantially Equivalent |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | Jun 16, 1988 | Substantially Equivalent |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | May 18, 1988 | Substantially Equivalent |
| K880960 | NDYAG LASER TRACHEAL TUBE | Apr 29, 1988 | Substantially Equivalent |