Atlas FDA

AQ HYDROPHILIC STENT

FDA 510(k) clearance K961446 · decided 1996-05-28

Clearance details

K-number
K961446
Device name
AQ HYDROPHILIC STENT
Applicant
Cook Urological, Inc.
Decision
Substantially Equivalent
Date received
1996-04-16
Decision date
1996-05-28
Days to decision
42 days
Clearance type
Traditional
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Spencer, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, st recall (Z-0852-2011)Vance Products Incorporated2011-01-05
Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/2 recall (Z-0980-2009)Vance Products Incorporated2009-02-10
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook Urologic recall (Z-0839-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook Urologic recall (Z-0840-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook Urologic recall (Z-0841-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urologic recall (Z-0842-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urologic recall (Z-0843-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook Urologic recall (Z-0844-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook Urologic recall (Z-0845-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook Urologic recall (Z-0846-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook Urologic recall (Z-0847-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook Urologic recall (Z-0848-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook Urologic recall (Z-0849-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urologic recall (Z-0850-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook Urologic recall (Z-0851-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook Urologic recall (Z-0852-2009)Vance Products Incorporated2009-01-23
Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, recall (Z-0853-2009)Vance Products Incorporated2009-01-23