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510(k) K191438

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector by Erbe USA, Inc. — Product Code OCX

K191438 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector". The FDA issued a decision of Substantially Equivalent on June 27, 2019. The device falls under product code OCX (Endoscopic Irrigation/Suction System), 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
June 27, 2019
Date Received
May 30, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Erbe USA, Inc.

  • K221177 — Erbe's Tubing/Cap Sets (August 11, 2022)
  • 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)
  • K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYB (December 17, 2013)
  • 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 OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)

FDA data resources