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

Anti Fog Solution And Accessories, Endoscopy

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

OCT is the FDA product code for Anti Fog Solution And Accessories, Endoscopy, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To prevent, reduce or eliminate condensation (fog) on endoscopic lens". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OCT
Device name
Anti Fog Solution And Accessories, Endoscopy
FDA definition
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
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
27
Ingested recalls
2

Clearances, product code OCT

By decision year
27 clearances under product code OCT with a decision year between 1991 and 2025, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OCT by decision year
YearClearances
19912
19933
19944
19951
19971
19981
20001
20021
20051
20071
20081
20101
20111
20121
20161
20171
20191
20201
20221
20241
20251

Applicants with the most clearances

Product code OCT
Applicants holding the most 510(k) clearances under product code OCT
ApplicantClearances
Minimally Invasive Devices, LLC2
Advanced Medical Design Co., Ltd.1
Anago, Inc.1
Batrik Medical Manufacturing Inc.1
DeRoyal Industries, Inc.1
Eagle Medical Intl.1
Highpoint Medical Corp.1
Inman Liebelt Corp.1
Jdi Surgical, Inc.1
Mectra Labs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order