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

Cystotome

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HNY is the FDA product code for Cystotome, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HNY
Device name
Cystotome
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
0

Clearances, product code HNY

By decision year
20 clearances under product code HNY with a decision year between 1979 and 1996, 1988 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code HNY by decision year
YearClearances
19791
19832
19844
19851
19861
19873
19887
19961

Applicants with the most clearances

Product code HNY
Applicants holding the most 510(k) clearances under product code HNY
ApplicantClearances
Advanced Surgical Products, Inc.6
Sharpoint, Inc.2
Cilco, Inc.1
Contemporary Surgical Systems, Inc.1
CooperVision, Inc.1
Look, Inc.1
Miami Eye Technology, Inc.1
Myocure, Inc.1
Noetix, Inc.1
Precision-Cosmet Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 70 companies shown, in name order