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FDA 510(k)

SUTURE STRIP

K-Number: K842621 · 1984-10-25

ApplicantGenetic Laboratories, Inc.
Decision Date1984-10-25
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUTURE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Laboratories, Inc.. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K842621. 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 SUTURE STRIP?

SUTURE STRIP is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Genetic Laboratories, Inc.. The 510(k) number is K842621.

When did SUTURE STRIP receive FDA 510(k) clearance?

SUTURE STRIP received FDA 510(k) clearance on 1984-10-25, under 510(k) number K842621.

Who is the listed applicant for SUTURE STRIP?

The FDA 510(k) record lists Genetic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTURE STRIP?

The FDA product code for SUTURE STRIP is FPX.

Related Clinical Trials

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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Other records listing Genetic Laboratories, Inc. 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.

K842066PERI-GUARD PERICARDIAL PATCHK821532PERIGUARD PERICARDIAL PATCH

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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