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510(k) K834401

URETERAL DOUBLE PIGTAIL STENT by Hobbs Medical, Inc. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

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  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
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  • K232920 — RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent (March 22, 2024)
  • K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima AP (November 10, 2022)
  • K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone doub (June 8, 2022)
  • K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Ki (March 17, 2022)
  • K213186 — NovoFlow Reinforced Ureteral Stent (February 16, 2022)