ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5— 510(k) K021717

Clearance details

Applicant

World of Medicine Lemke GmbH

Product code

Code GCT

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2002-05-23

Decision date

2002-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cambridge, MA, US

• K093125 — ALPHAXENON LIGHT 180 W AND 300 W2010-01-27
• K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 201326202008-12-18
• K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE2007-08-20
• K040949 — VIADUCT MINISCOPE AND ACCESSORIES2004-05-07
• K022490 — KSEA MEDI PACK2003-09-29

• K024251 — SIGHTFIX2003-03-18
• K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L32003-01-14
• K021456 — ER150/M22002-08-01
• K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L32002-06-05
• K014158 — ENDOSCOPIC CAMERA TC804/C42002-03-14

Malfunction

1,393

Other

2

Total

1,395

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 →