INTUBATION ENDOSCOPE AND INTRODUCER SHEATH— 510(k) K970107

Name: FDA 510(k) clearance K970107
Creator: U.S. Food and Drug Administration
Published: 1997-11-18

Substantially Equivalent

Urohealth Systems, Inc.

FDA 510(k) clearance K970107 for INTUBATION ENDOSCOPE AND INTRODUCER SHEATH, Substantially Equivalent on 1997-11-18. Applicant: Urohealth Systems, Inc.. Device class: 2.

Clearance details

Applicant: Urohealth Systems, Inc.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1997-01-13
Decision date: 1997-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EOQ

view all

K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more2026-09-02
K260382 — MONARCH Platform (MON-000008)2026-07-25
K254037 — LungFlow Airway Catheter2026-07-10
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14

More clearances from Urohealth Systems, Inc.

view all

K980617 — MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER1998-04-09
K972510 — PIVOTAL SCISSOR1997-11-13

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.