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FDA 510(k)

OP-SITE SKIN CLOSURE SUTURE ADHESIVE

K-Number: K801884 · 1980-10-10

ApplicantAcme United Corp.
Decision Date1980-10-10
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OP-SITE SKIN CLOSURE SUTURE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K801884. The device is classified under product code FPX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-SITE SKIN CLOSURE SUTURE ADHESIVE?

OP-SITE SKIN CLOSURE SUTURE ADHESIVE is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Acme United Corp.. The 510(k) number is K801884.

When did OP-SITE SKIN CLOSURE SUTURE ADHESIVE receive FDA 510(k) clearance?

OP-SITE SKIN CLOSURE SUTURE ADHESIVE received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801884.

Who is the listed applicant for OP-SITE SKIN CLOSURE SUTURE ADHESIVE?

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

What is the FDA product code for OP-SITE SKIN CLOSURE SUTURE ADHESIVE?

The FDA product code for OP-SITE SKIN CLOSURE SUTURE ADHESIVE is FPX.

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Other records listing Acme United Corp. as applicant

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Related Devices (Code: FPX)

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.

K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.K952947DELPORE SKIN CLOSUREBitco Intl.K952702DERMA SEALTtl MedicalK946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.K931005DUKAL SKIN CLOSURE STRIPDukal Corp.K921775SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.

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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