510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCVClass II

Endoscopic Leak Tester

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PCV is the FDA product code for Endoscopic Leak Tester, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PCV
Device name
Endoscopic Leak Tester
FDA definition
An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PCV

By decision year
2 clearances under product code PCV with a decision year between 2013 and 2021, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCV by decision year
YearClearances
20131
20211

Applicants with the most clearances

Product code PCV
Applicants holding the most 510(k) clearances under product code PCV
ApplicantClearances
Olympus Medical Systems Corp.1
PENTAX of America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code