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510(k) K012074

XBO1-824-18/19/20 BIOPSY FORCEPS by The Olympus Optical Co. — Product Code OCZ

K012074 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "XBO1-824-18/19/20 BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on September 25, 2001. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2001
Date Received
July 2, 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 The Olympus Optical Co.

  • K032066 — SONOSURG SYSTEM (October 3, 2003)
  • K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (March 24, 2003)
  • K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (February 12, 2003)
  • K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
  • K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H (December 23, 2002)
  • K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)

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