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

Proctoscope

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

GCF is the FDA product code for Proctoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GCF
Device name
Proctoscope
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
1

Clearances, product code GCF

By decision year
2 clearances under product code GCF with a decision year between 1979 and 1995, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GCF by decision year
YearClearances
19791
19951

Applicants with the most clearances

Product code GCF
Applicants holding the most 510(k) clearances under product code GCF
ApplicantClearances
C. Intl.1
Karl Storz Endoscopy-America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code