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510(k) K941464

BASICS ENDOSCOPY SYSTEM by Cox Medical Ent., Inc. — Product Code OCZ

K941464 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "BASICS ENDOSCOPY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
March 28, 1994
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 Cox Medical Ent., Inc.

  • K950689 — UCB (March 6, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K940911 — BASICS ENDOSCOPY SYSTEM (May 16, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K935250 — ACCU-PATH (January 21, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K914466 — COX DISPOSABLE CYTOLOGY BRUSHES (October 25, 1991)

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