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

Trephine, Manual, Ophthalmic

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

HRH is the FDA product code for Trephine, Manual, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HRH
Device name
Trephine, Manual, Ophthalmic
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
12
Ingested recalls
1

Clearances, product code HRH

By decision year
12 clearances under product code HRH with a decision year between 1977 and 2002, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HRH by decision year
YearClearances
19771
19781
19811
19841
19851
19863
19872
19941
20021

Applicants with the most clearances

Product code HRH
Applicants holding the most 510(k) clearances under product code HRH
ApplicantClearances
Precision Instruments, Inc.3
Cerenovus, Inc.1
Deknatel, Inc.1
Edward Weck, Inc.1
Intramed Laboratories, Inc.1
Richmond Products, Inc.1
Steinway Instrument Co., Inc.1
Stephens Instruments, Inc1
Storz Instrument Co.1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order