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510(k) K931201

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER by Tri-Med Specialties, Inc. — Product Code OCX

K931201 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER". The FDA issued a decision of Substantially Equivalent on September 28, 1993. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1993
Date Received
March 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Tri-Med Specialties, Inc.

  • K971615 — PATTISON ESOPHAGEAL DILATOR (July 24, 1997)
  • K970890 — #ES-32 SUCTION CATHETER 32 FR. (May 23, 1997)
  • K970982 — T-RX RETRIEVAL FORCEPS (May 9, 1997)
  • K942918 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (February 28, 1995)
  • K950574 — NEEDLE/CANNULA (February 24, 1995)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K945160 — PARACENTESIS NEEDLES/CANNULAS (November 14, 1994)
  • K924549 — TRI-MED QUICK-STEP(TM) RECTAL TUBE (February 10, 1994)
  • K932015 — TRI-MED INFLATABLE ESOPHAGEAL DILATOR (February 3, 1994)
  • K932652 — TRI-MED PARACENTESIS TRAY (November 24, 1993)

Other clearances for product code OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)

FDA data resources