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ORskin Blue

Megabay S.A.

Country / region:Argentina (AR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Megabay S.A.
Argentina (AR)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K232858
Device name
ORskin Blue
Company
Megabay S.A.
Country / region
Argentina(AR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-09-15
Decision date
2024-05-01
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

ORskin Blue is intended for incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.

Intended Use

ORskin Blue is intended for incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.

Summary parsed at:2026-06-01 05:26:36 UTC

Predicate devices

0

No predicate K numbers were extracted

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Cited as predicate

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