510(k) K123704

Device: AUTOMATED ENDOSCOPE LEAK TESTER
Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
510(k) number: K123704
Product code: PCV
Decision: Substantially Equivalent (SESE)
Decision date: 2013-02-04
Date received: 2012-12-03
Regulation: 876.1500
Classification name: Endoscopic Leak Tester
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAPHNEY GERMAIN-KOLAWOLE
Address: Regulatory Affairs & Quality Assurance 3500 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

2518897
8010047
3002808148

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04953170415180	AUTOMATED ENDOSCOPE LEAK TESTER	OLYMPUS MEDICAL SYSTEMS CORP.	2021-12-17
04953170351792	ALT-PRO INTERFACE CABLE	OLYMPUS MEDICAL SYSTEMS CORP.	2016-09-21
04953170351785	ALT-Pro WALL-MOUNT	OLYMPUS MEDICAL SYSTEMS CORP.	2016-09-21
04953170351778	ALT-Pro LEAK TEST AIR TUBE	OLYMPUS MEDICAL SYSTEMS CORP.	2016-09-21
04953170351761	List of Compatible Endoscopes	OLYMPUS MEDICAL SYSTEMS CORP.	2016-09-21

Other 510(k) Records For Product Code PCV #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K212201	PENTAX Medical Auto Leakage Tester SHA-P6	Pentax of America, Inc.	2021-10-01

Legacy Summary#

summary

FDA Review#

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