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

Endoscope Maintenance System

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

PUP is the FDA product code for Endoscope Maintenance System, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PUP
Device name
Endoscope Maintenance System
FDA definition
To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PUP

By decision year
1 clearance under product code PUP with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUP by decision year
YearClearances
19861

Applicants with the most clearances

Product code PUP
Applicants holding the most 510(k) clearances under product code PUP
ApplicantClearances
Buckman Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code