CIRCON ACMI BICAP III THERAPEUTIC SYSTEM— 510(k) K884254

Name: FDA 510(k) clearance K884254
Creator: U.S. Food and Drug Administration
Published: 1989-01-11

Substantially Equivalent

Circon Acmi

FDA 510(k) clearance K884254 for CIRCON ACMI BICAP III THERAPEUTIC SYSTEM, Substantially Equivalent on 1989-01-11. Applicant: Circon Acmi. Device class: 2.

Clearance details

Applicant: Circon Acmi
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1988-10-11
Decision date: 1989-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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 Circon Acmi

view all

K013165 — USA SERIES LAPAROSCOPES2002-01-18
K980492 — AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)1998-11-17
K905705 — LAP 3501 HIGH FLOW INSUFFLATOR1991-02-28
K905706 — GYN-1500 HYSTEROSCOPIC INUFFLATOR1991-02-28
K884097 — MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES1989-04-17

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 →

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