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510(k) K010412

FLEXIBLE ENDOSCOPIC SCISSORS by Telemed Systems, Inc. — Product Code OCZ

K010412 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "FLEXIBLE ENDOSCOPIC SCISSORS". The FDA issued a decision of Substantially Equivalent on April 2, 2001. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2001
Date Received
February 12, 2001
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 Telemed Systems, Inc.

  • K020379 — PPD BALLOON DILATATION CATHETER (May 6, 2002)
  • K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (March 1, 2002)
  • K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 (December 22, 1999)
  • K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM (December 22, 1999)
  • K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUS (January 21, 1998)
  • K974300 — TELEMED SYSTEMS RETRIEVAL BASKET (December 19, 1997)
  • K901435 — GASTROINTESTINAL CYTOLOGY BRUSH (July 16, 1990)
  • K901427 — BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON (June 22, 1990)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)
  • K901424 — ESOPHAGEAL BALLOON DILATOR (June 21, 1990)

Other clearances for product code OCZ

  • K252800 — KARL STORZ Endoscopic Accessories for Urology (June 3, 2026)
  • 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)

FDA data resources