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
GCWClass II

Transformer, Endoscope

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

GCW is the FDA product code for Transformer, Endoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 6 recalls.

Classification record

Product code
GCW
Device name
Transformer, Endoscope
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
6

Clearances, product code GCW

By decision year
1 clearance under product code GCW with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GCW by decision year
YearClearances
19771

Applicants with the most clearances

Product code GCW
Applicants holding the most 510(k) clearances under product code GCW
ApplicantClearances
Welch Allyn Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code