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FDA 510(k)

MICROPOROUS HYPOALLERGENIC

K-Number: K840946 · 1984-08-17

ApplicantGainor Medical
Decision Date1984-08-17
Product CodeKGW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROPOROUS HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K840946. The device is classified under product code KGW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPOROUS HYPOALLERGENIC?

MICROPOROUS HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Gainor Medical. The 510(k) number is K840946.

When did MICROPOROUS HYPOALLERGENIC receive FDA 510(k) clearance?

MICROPOROUS HYPOALLERGENIC received FDA 510(k) clearance on 1984-08-17, under 510(k) number K840946.

Who is the listed applicant for MICROPOROUS HYPOALLERGENIC?

The FDA 510(k) record lists Gainor Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROPOROUS HYPOALLERGENIC?

The FDA product code for MICROPOROUS HYPOALLERGENIC is KGW.

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Other records listing Gainor Medical as applicant

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.

K850100BLOOD LANCETK850150ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MEDK844306GAINOR MEDICAL SYRINGEK844305GAINOR MEDICAL FLOWMAX NEEDLESK840945SKIN CLOSUREK840950ZINC OXIDE TAPE

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Related Devices (Code: KGW)

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.

K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)Applied Medical Resources CorporationK253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)Applied Medical Resources CorporationK113268ALEXIS O WOUND PROTECTOR/RETRACTORApplied Medical Resources Corp.K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORApplied Medical Resources Corp.K093296ALEXIS LAPAROSCOPIC SYSTEMApplied Medical Resources Corp.K062907ALEXIS WOUND RETRACTORApplied Medical Resources

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.

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