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FDA 510(k)

BIOGEL ORTHOPRO INDICATOR UNDERGLOVE

K-Number: K101163 · 2010-11-23

ApplicantMolnlycke Health Care USA
Decision Date2010-11-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOGEL ORTHOPRO INDICATOR UNDERGLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care USA. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K101163. 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 ORTHOPRO INDICATOR UNDERGLOVE?

BIOGEL ORTHOPRO INDICATOR UNDERGLOVE is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Molnlycke Health Care USA. The 510(k) number is K101163.

When did BIOGEL ORTHOPRO INDICATOR UNDERGLOVE receive FDA 510(k) clearance?

BIOGEL ORTHOPRO INDICATOR UNDERGLOVE received FDA 510(k) clearance on 2010-11-23, under 510(k) number K101163.

Who is the listed applicant for BIOGEL ORTHOPRO INDICATOR UNDERGLOVE?

The FDA 510(k) record lists Molnlycke Health Care USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGEL ORTHOPRO INDICATOR UNDERGLOVE?

The FDA product code for BIOGEL ORTHOPRO INDICATOR UNDERGLOVE is KGO.

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Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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