Decision Date2012-01-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BIOGEL (R) INDICATOR (R) UNDERGLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2012-01-30 under 510(k) number K111413. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BIOGEL (R) INDICATOR (R) UNDERGLOVE?
BIOGEL (R) INDICATOR (R) UNDERGLOVE is a medical device that received FDA 510(k) clearance on 2012-01-30. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K111413.
When did BIOGEL (R) INDICATOR (R) UNDERGLOVE receive FDA 510(k) clearance?
BIOGEL (R) INDICATOR (R) UNDERGLOVE received FDA 510(k) clearance on 2012-01-30, under 510(k) number K111413.
Who is the listed applicant for BIOGEL (R) INDICATOR (R) UNDERGLOVE?
The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIOGEL (R) INDICATOR (R) UNDERGLOVE?
The FDA product code for BIOGEL (R) INDICATOR (R) UNDERGLOVE is KGO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.