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

Confocal Optical Imaging

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

OWN is the FDA product code for Confocal Optical Imaging, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Collection of light signals for visualization of cellular microstructures". As of , FDA records hold 62 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
OWN
Device name
Confocal Optical Imaging
FDA definition
Collection of light signals for visualization of cellular microstructures.
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
No
Ingested clearances
63
Ingested recalls
4

Clearances, product code OWN

By decision year
63 clearances under product code OWN with a decision year between 2011 and 2026, 2019 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OWN by decision year
YearClearances
20111
20123
20132
20145
20155
20162
20175
20181
20197
20207
20214
20224
20236
20241
20253
20267

Applicants with the most clearances

Product code OWN
Applicants holding the most 510(k) clearances under product code OWN
ApplicantClearances
Mauna Kea Technologies16
Stryker Corp.8
Karl Storz Endoscopy-America, Inc.6
Karl Storz SE & Co. KG4
Novadaq Technologies ULC. (Now A Part of Stryker)4
Visionsense, Ltd.4
Activ Surgical Inc2
Medtronic, Inc.2
Olympus Medical Systems Corp.2
Daniel & Daniel Consulting1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order