IEC MEDSIGHT AND MEDBRIGHT— 510(k) K080809

Name: FDA 510(k) clearance K080809
Creator: U.S. Food and Drug Administration
Published: 2008-08-11

Substantially Equivalent

Innovative Endoscopy Components, LLC

FDA 510(k) clearance K080809 for IEC MEDSIGHT AND MEDBRIGHT, Substantially Equivalent on 2008-08-11. Applicant: Innovative Endoscopy Components, LLC. Device class: 2.

Clearance details

Applicant: Innovative Endoscopy Components, LLC
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-21
Decision date: 2008-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FET

view all

K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB2026-09-10
K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K261260 — HD Camera Head OLYMPUS CH-S200-08-LB2026-06-24
K251734 — ProVee Video Processing Unit (PV-003)2025-09-24
K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)2025-08-11

More clearances from Innovative Endoscopy Components, LLC

view all

K062707 — RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE2006-12-08
K992983 — BAHO AUTOCLAVABLE CYSTOSCOPE1999-10-07

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.