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

Endoscope, Battery-Powered And Accessories

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

GCS is the FDA product code for Endoscope, Battery-Powered And Accessories, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GCS
Device name
Endoscope, Battery-Powered And Accessories
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
9
Ingested recalls
0

Clearances, product code GCS

By decision year
9 clearances under product code GCS with a decision year between 1992 and 1995, 1993 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GCS by decision year
YearClearances
19921
19936
19941
19951

Applicants with the most clearances

Product code GCS
Applicants holding the most 510(k) clearances under product code GCS
ApplicantClearances
Inman Medical Corp.2
Aesculap Inc1
Baxter Healthcare Corporation1
Ideal Medical, Inc.1
Instrument Makar, Inc.1
Laparomed Corp.1
Leisegang Medical, Inc.1
M.I.S. Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code