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510(k) K970982

T-RX RETRIEVAL FORCEPS by Tri-Med Specialties, Inc. — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
March 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Other clearances by Tri-Med Specialties, Inc.

  • K971615 — PATTISON ESOPHAGEAL DILATOR (July 24, 1997)
  • K970890 — #ES-32 SUCTION CATHETER 32 FR. (May 23, 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)
  • K931201 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (September 28, 1993)

Other clearances for product code OCZ

  • K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cut (December 20, 2024)
  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K152802 — Grasping Forceps (January 21, 2016)
  • K150939 — Ensizor Endoscopic Scissors (June 8, 2015)
  • K141058 — ENSIZOR ENDOSCOPIC SCISSORS (August 1, 2014)
  • K133736 — ENDOSCOPIC SUTURE CUTTER (January 7, 2014)
  • K120084 — ENDOSCOPIC RETRIEVAL DEVICE (May 30, 2012)
  • K103688 — G-PROX EZ ENDOSCOPIC GRASPER (January 14, 2011)
  • K101298 — ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE (August 5, 2010)
  • K072684 — MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (January 4, 2008)