ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL— 510(k) K881469

Name: FDA 510(k) clearance K881469
Creator: U.S. Food and Drug Administration
Published: 1988-09-12

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K881469 for ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL, Substantially Equivalent on 1988-09-12. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-07
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FER

view all

K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)2025-10-09
K242668 — Gastro Concepts Air Assist2024-12-13
K230439 — WellCare Anoscope2023-12-22
K200021 — Applied Medical Anoscope2021-01-06
K171701 — GelPOINT Path Transanal Access Platform2017-07-20

More clearances from Baxter Healthcare Corp

view all

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