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510(k) K800969

M.R. ASSOC. CANNULAS by Mr Associates, Inc. — Product Code OCZ

K800969 is an FDA 510(k) premarket notification submitted by Mr Associates, Inc. for the device "M.R. ASSOC. CANNULAS". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Mr Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 23, 1980
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 Mr Associates, Inc.

  • K800963 — BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. (May 8, 1980)
  • K800974 — M.R. ASSOC. POWER CORD (May 8, 1980)
  • K800967 — M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS (May 8, 1980)
  • K800968 — M.R. ASSOC. RAT TOOTH GRASP FORCEPS (May 8, 1980)
  • K800966 — M.R. ASSOC. CYTOLOGY BRUSHES (May 8, 1980)
  • K800962 — M.R. ASSOC. WASHING TUBE/MEASURING TUBE (May 8, 1980)
  • K800972 — M.R. ASSOC. TRIPOD GRASPING FORCEPS (May 8, 1980)
  • K800964 — M.R. ASSOC. BALL TYPE COAGULATOR (May 8, 1980)
  • K800973 — M.R. ASSOC. HOT BIOPSY FORCEPS (May 8, 1980)
  • K800975 — M.R. ASSOC. TRUE-FEEL HANDLE (May 8, 1980)

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