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510(k) K921838

ACUCISE URETERAL CUTTING CATHETER by Applied Urology, Inc. — Product Code EYB

K921838 is an FDA 510(k) premarket notification submitted by Applied Urology, Inc. for the device "ACUCISE URETERAL CUTTING CATHETER". The FDA issued a decision of Substantially Equivalent on February 26, 1993. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Applied Urology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1993
Date Received
April 17, 1992
Clearance Type
Traditional
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 Applied Urology, Inc.

  • K925282 — UROLOGICAL CATHETER AND ACCESSORIES (January 13, 1993)
  • K920695 — URETERAL STENT (September 23, 1992)
  • K915219 — URETHRAL ELECTRODE SHEATH (July 23, 1992)
  • K912093 — DISPOSABLE ASPIRATION IRRIGATION SYSTEM (April 24, 1992)
  • K920030 — SURESEAL ENDOSCOPIC VALVE (March 18, 1992)
  • K912656 — ENDOSCOPIC ELECTRODE (September 16, 1991)
  • K912903 — PERCUTANEOUS RETRACTOR KIT (August 16, 1991)
  • K905731 — FLEXIBLE ENDOSCOPIC ELECTRODE (January 31, 1991)
  • K903994 — URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION (October 19, 1990)
  • K901214 — RIGID URETEROSCOPE (June 1, 1990)

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