Home / 510(k) Clearances / K173734

510(k) K173734

RocaJJ Soft Stents by Promepla Sam — Product Code FAD

K173734 is an FDA 510(k) premarket notification submitted by Promepla Sam for the device "RocaJJ Soft Stents". The FDA issued a decision of Substantially Equivalent on March 12, 2018. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Promepla Sam has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2018
Date Received
December 6, 2017
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 Promepla Sam

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K152278 — ENDOFLOW II - Irrigation, Warming and Suction System (February 9, 2016)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)

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