ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE— 510(k) K905282

Clearance details

Applicant

Frantz Medical Development, Ltd.

Product code

Code GCT

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

1990-11-23

Decision date

1991-03-19

Decision

Unknown

Clearance type

Traditional

Location

New York, NY, 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

• K981541 — CLEARSTAR ENTERAL NUTRITION PUMP1998-08-13
• K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP1987-11-05
• K871710 — BIOPSY FORCEPS1987-08-10
• K863508 — FRANTZ MEDICAL ELECTRODE1987-02-06

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 →