Erbe's Tubing/Cap Sets— 510(k) K221177

Substantially Equivalent

Erbe USA, Inc.

FDA 510(k) clearance K221177 for Erbe's Tubing/Cap Sets, Substantially Equivalent on 2022-08-11. Applicant: Erbe USA, Inc.. Device class: 2.

Clearance details

Applicant: Erbe USA, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-04-25
Decision date: 2022-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCX

K251986 — AUXILIARY WATER TUBE MAJ-8552025-09-26
K251997 — Single-Use Biopsy Valve (MAJ-1555)2025-09-25
K242586 — ArgoCap (200.52)2025-05-22
K241704 — Endoscopic Water Pump2025-03-20
K242357 — Water Container (MAJ-901); Water Container (MAJ-902)2024-10-07

More clearances from Erbe USA, Inc.

K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector2019-06-27
K190469 — ERBEFLO 2 Disposable Tubing System2019-05-23
K182444 — ERBEFLO Olympus Scope Port Connector2018-11-06
K162152 — Erbes CO2 Tubing/Cap Sets2016-08-31
K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe2015-10-27

Recalls naming K221177

K-number listed on FDA's recall record

Z-2063-2026 — ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;Class II·Ongoing·Erbe Medical, LLC·20260331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221177.

Data sourced from openFDA. This site is unofficial and independent of the FDA.