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

Endoscope, Ophthalmic

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

KYH is the FDA product code for Endoscope, Ophthalmic, 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 no recalls.

Classification record

Product code
KYH
Device name
Endoscope, Ophthalmic
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
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code KYH

By decision year
1 clearance under product code KYH with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KYH by decision year
YearClearances
19941

Applicants with the most clearances

Product code KYH
Applicants holding the most 510(k) clearances under product code KYH
ApplicantClearances
Gm Engineering, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code