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510(k) K102179

ENVIEW (TM) by Carefusion 2200 — Product Code OCV

K102179 is an FDA 510(k) premarket notification submitted by Carefusion 2200 for the device "ENVIEW (TM)". The FDA issued a decision of Substantially Equivalent on December 2, 2010. The device falls under product code OCV (Endoscope Holder), a Class II device regulated under 21 CFR 876.1500. Carefusion 2200 has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2010
Date Received
August 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To hold endoscope in a desired position during procedures.

Other clearances by Carefusion 2200

  • K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV (March 4, 2021)
  • K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (May 4, 2017)
  • K162432 — Multi-Link X2 ECG Cable and Lead Wire System (January 18, 2017)
  • K160764 — AirLife Autofill Humidification Chamber (August 25, 2016)
  • K153554 — Genesis Low Temperature Reusable Rigid Container System (March 21, 2016)
  • K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instrum (February 1, 2016)
  • K142529 — Genesis Reusable Rigid Container System (January 8, 2015)
  • K140850 — GENESIS REUSABLE RIGID CONTAINER SYSTEM (August 27, 2014)
  • K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (April 21, 2014)
  • K113407 — SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS (September 7, 2012)

Other clearances for product code OCV

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K232405 — ENDOFIX EXO (April 25, 2024)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (December 23, 2009)
  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K990334 — KSEA ENDOSCOPE HOLDER (March 22, 1999)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)

FDA data resources