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510(k) K854908

UROFLEX by Angiomed U.S., Inc. — Product Code FAD

K854908 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "UROFLEX". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
December 9, 1985
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

Other clearances by Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)
  • K855142 — ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY (March 11, 1986)

Other clearances for product code FAD

  • K251890 — Disposable Ureteral Stents (February 20, 2026)
  • K251469 — Endura™ Ureteral Stent and Stent Set (December 19, 2025)
  • K243039 — Ureteral Stents (AF-D series) (June 18, 2025)
  • K243830 — Disposable ureteral stent (May 14, 2025)
  • K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDriv (April 15, 2025)
  • 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)

FDA data resources