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510(k) K132340

ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 by Erbe USA, Inc. — Product Code FEQ

K132340 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1". The FDA issued a decision of Substantially Equivalent on December 17, 2013. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Erbe USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2013
Date Received
July 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Pump, Air, Non-Manual, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Erbe USA, Inc.

  • K221177 — Erbe's Tubing/Cap Sets (August 11, 2022)
  • K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (June 27, 2019)
  • K190469 — ERBEFLO 2 Disposable Tubing System (May 23, 2019)
  • K182444 — ERBEFLO Olympus Scope Port Connector (November 6, 2018)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (October 27, 2015)
  • K151041 — ERBECRYO 2 Cryosurgical Unit with accessories (May 4, 2015)
  • K143186 — Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope P (December 18, 2014)
  • K133180 — ERBE ESU MODEL VIO DV WITH ACCESSORIES (December 11, 2013)
  • K103696 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES S (March 22, 2011)

Other clearances for product code FEQ

  • K220395 — EndoGator Endoscopy Irrigation Tubing (March 11, 2022)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO (January 4, 2017)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K153362 — AquaShield system CO2, AquaShield system-PENTAX (December 16, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)

FDA data resources