Home / 510(k) Clearances / K033368

510(k) K033368

FOSSA URETERAL OPEN LUMEN STENT by Fossa Medical, Inc. — Product Code EYB

K033368 is an FDA 510(k) premarket notification submitted by Fossa Medical, Inc. for the device "FOSSA URETERAL OPEN LUMEN STENT". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Fossa Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
October 21, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Fossa Medical, Inc.

  • K072293 — FOSSA URETERAL OPEN STENTS (August 6, 2008)
  • K031292 — MODIFICATION TO FOSSA URETERAL STONE SWEEPER (May 22, 2003)

Other clearances for product code EYB

  • K192183 — RocaTub Ureteral Catheter (April 23, 2020)
  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)
  • K183323 — UPJ Occlusion Balloon Catheter (August 5, 2019)
  • K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (June 17, 2019)
  • K182122 — Ureteric Catheters (October 4, 2018)
  • K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet (September 14, 2018)
  • K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C (December 21, 2017)
  • K133750 — OCCLUDER OCCLUSION BALLOON CATHETER (January 8, 2014)
  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
  • K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (March 3, 2009)

FDA data resources