FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIALY-NATE SET & DIALY-NATE CATHETER
K Number: K872221
·
Decision Oct 13, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
15
Applicant Total
26
Review Days
126
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
- DIALY-NATE SET & DIALY-NATE CATHETER
- K Number
- K872221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gesco Intl., Inc.
- Date Received
- June 9, 1987
- Decision Date
- October 13, 1987
- Product Code
- FKO
- 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 |
|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKO), ordered by most recent decision date.
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERITONEAL DIALYSIS CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TITANIUM CONNECTOR (2 PART)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMUKIN 50% - AIRSPRAY(R)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED USE OF PULL-APART INTRODUCER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |