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

Catheter, Rectal

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GBT is the FDA product code for Catheter, Rectal, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GBT
Device name
Catheter, Rectal
Regulation
21 CFR 876.5980
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
Yes
Ingested clearances
3
Ingested recalls
1

Clearances, product code GBT

By decision year
3 clearances under product code GBT with a decision year between 1989 and 1994, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GBT by decision year
YearClearances
19891
19942

Applicants with the most clearances

Product code GBT
Applicants holding the most 510(k) clearances under product code GBT
ApplicantClearances
Innovatec Medical Corp.1
Tonometrics, Inc.1
Tri-Med Specialties, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code