Product areas
FDA product code distribution
Omniguide, Inc.
Country / region:United States (US)
510(k) submissions
3
Filtered: GEX
Latest clearance
2021-01-14
Product codes
1
GEX
Cited as predicate
0
510(k) submissions
3 total · filtered by GEX
Company profile
- Canonical name
- Omniguide, Inc.
- Country
- United States(US)
Cited predicates
18- K093451
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Not ingested - K073313
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Not ingested - K965241
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Not ingested - K962396
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Not ingested - K960009
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Not ingested - K900533
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Not ingested - K183319
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Not ingested - K140378
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Not ingested - K081939
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Not ingested - K070157
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Not ingested - K070157
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Not ingested - K093251
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Not ingested - K093451
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Not ingested - K100384
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Not ingested - K140378
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Not ingested - K151331
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K864378
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Not ingested - K945648
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Not ingested
Omniguide, Inc. references 18 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list Omniguide, Inc. as a predicate