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

Microscope, Surgical

21 CFR 878.4700 / General, Plastic Surgery
FDA source (opens on fda.gov)

EPT is the FDA product code for Microscope, Surgical, a class I device type, regulated under 21 CFR 878.4700. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
EPT
Device name
Microscope, Surgical
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
14

Clearances, product code EPT

By decision year
18 clearances under product code EPT with a decision year between 1976 and 1994, 1982 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code EPT by decision year
YearClearances
19761
19813
19825
19831
19851
19861
19882
19901
19932
19941

Applicants with the most clearances

Product code EPT
Applicants holding the most 510(k) clearances under product code EPT
ApplicantClearances
Storz Instrument Co.4
Carl Zeiss, Inc.3
JEDMED Instrument Company2
Kelleher Corp.2
Alcon Laboratories1
Micrins Surgical, Inc.1
Microdyne, Inc.1
Surgi-Quip Inc.U1
Teknar, Inc.1
The Lebanon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 71 companies shown, in name order