Product code ODF

Device name: Mini Endoscope, Gastroenterology-Urology
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.1500
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K092739	MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE	C-Link Micro Imaging, Inc.	2010-01-12
K091962	POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200	Lumenis, Inc.	2009-09-30
K090170	SPYSCOPE ACCESS AND DELIVERY CATHETER	Boston Scientific Corp	2009-02-04
K052194	SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR	Boston Scientific Corp	2005-08-24
K050403	SPYGLASS DIRECT VISULATION PROBE	Boston Scientific Corp	2005-03-04
K963354	5 STAR MEDICAL ENDOSCOPE	Five Star Medical, Inc.	1997-09-08
K943593	SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM	Ovamed Corp.	1995-03-22
K941230	MINI-UB ENDOSCOPES	Candela Laser Corp.	1994-06-17
K933106	ENDOSCOPE	Origin Medsystems, Inc.	1993-10-19
K912089	MODIFIED SERIES 2100 ENDOSCOPES	Medical Laser, Inc.	1991-08-12
K910732	CANDELA MINI-UB ENDOSCOPE	Candela Laser Corp.	1991-04-12
K874858	LASERTRIPTER MINISCOPE	Candela Laser Corp.	1988-02-19

Related 510(k) Records#