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

Instrument, Vitreous Aspiration And Cutting, Battery-Powered

21 CFR 886.4150 / Ophthalmic
FDA source (opens on fda.gov)

HKP is the FDA product code for Instrument, Vitreous Aspiration And Cutting, Battery-Powered, a class II device type, regulated under 21 CFR 886.4150. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HKP
Device name
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
0

Clearances, product code HKP

By decision year
16 clearances under product code HKP with a decision year between 1976 and 1997, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HKP by decision year
YearClearances
19761
19771
19781
19793
19801
19812
19821
19831
19891
19901
19952
19971

Applicants with the most clearances

Product code HKP
Applicants holding the most 510(k) clearances under product code HKP
ApplicantClearances
Varian Assoc., Inc.3
Concept, Inc.2
Apyx Medical Corporation1
Coburn Optical Ind., Inc.1
Cooper Medical Devices Corp.1
CooperVision, Inc.1
Frigitronics of Connecticut, Inc.1
Grieshaber & Co.1
Medical Instrument Development Laboratories, Inc.1
Mentor O & O, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code