510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NWSClass II

Kit, Choledochoscope, Flexible And Rigid

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

NWS is the FDA product code for Kit, Choledochoscope, Flexible And Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Flexible and Rigid Choledochoscope Kit". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NWS
Device name
Kit, Choledochoscope, Flexible And Rigid
FDA definition
Flexible and Rigid Choledochoscope Kit
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
1
Ingested recalls
0

Clearances, product code NWS

By decision year
1 clearance under product code NWS with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NWS by decision year
YearClearances
19811

Applicants with the most clearances

Product code NWS
Applicants holding the most 510(k) clearances under product code NWS
ApplicantClearances
Olympus Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NWS.