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510(k) K871667

URETERAL STENT by Penn Medical Devices, Inc. — Product Code FAD

K871667 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "URETERAL STENT". The FDA issued a decision of Substantially Equivalent on June 10, 1987. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1987
Date Received
April 28, 1987
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 Penn Medical Devices, Inc.

  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K873176 — HUFFMAN BIOPSY UNIT (October 14, 1987)
  • K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE) (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862729 — PENN 3-RING HANDLE (October 24, 1986)
  • K862107 — PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (September 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