FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LESE STENTS SETS
K Number: K952513
·
Decision Jun 10, 1996
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
104
Review Days
377
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
- LESE STENTS SETS
- K Number
- K952513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Urological, Inc.
- Date Received
- May 30, 1995
- Decision Date
- June 10, 1996
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAD), ordered by most recent decision date.
Disposable Ureteral Stents
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endura Ureteral Stent and Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteral Stents (AF-D series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable ureteral stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cook Urological, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | May 6, 2011 | Substantially Equivalent |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Oct 9, 2009 | Substantially Equivalent |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Sep 3, 2009 | Substantially Equivalent |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Nov 7, 2008 | Substantially Equivalent |
| K082536 | COOK WIRE GUIDES | Oct 27, 2008 | Substantially Equivalent |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Sep 25, 2008 | Substantially Equivalent |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Apr 17, 2008 | Substantially Equivalent |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |