GYRUS ACMI BICOAG HEMOSTASIS PROBE— 510(k) K123319

Name: FDA 510(k) clearance K123319
Creator: U.S. Food and Drug Administration
Published: 2012-12-14

Substantially Equivalent

Olympus Surgical Technologies America

FDA 510(k) clearance K123319 for GYRUS ACMI BICOAG HEMOSTASIS PROBE, Substantially Equivalent on 2012-12-14. Applicant: Olympus Surgical Technologies America. Device class: 2.

Clearance details

Applicant: Olympus Surgical Technologies America
Product code: Product code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-26
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNS

view all

K262460 — Rezum System2026-09-03
K260962 — Sphincterotome2026-05-21
K252388 — Vanquish Water Vapor Ablation Device2025-11-26
K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

More clearances from Olympus Surgical Technologies America

view all

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K123319

K-number listed on FDA's recall record

Z-3247-2026 — Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Class II·Ongoing·Olympus Corporation of the Americas·20260819
Z-3244-2026 — Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Class II·Ongoing·Olympus Corporation of the Americas·20260819
Z-3246-2026 — Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Class II·Ongoing·Olympus Corporation of the Americas·20260819
Z-3245-2026 — Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Class II·Ongoing·Olympus Corporation of the Americas·20260819
Z-1481-2024 — Hemostasis Probe, Model: CD-B622LAClass II·Ongoing·Olympus Corporation of the Americas·20240105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123319.

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