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FDA 510(k)

POLYURETHANE PROD. FOR I.V. NEEDLES

K-Number: K771125 · 1977-08-02

ApplicantDevon Industries, Inc.
Decision Date1977-08-02
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYURETHANE PROD. FOR I.V. NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771125. 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 POLYURETHANE PROD. FOR I.V. NEEDLES?

POLYURETHANE PROD. FOR I.V. NEEDLES is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Devon Industries, Inc.. The 510(k) number is K771125.

When did POLYURETHANE PROD. FOR I.V. NEEDLES receive FDA 510(k) clearance?

POLYURETHANE PROD. FOR I.V. NEEDLES received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771125.

Who is the listed applicant for POLYURETHANE PROD. FOR I.V. NEEDLES?

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

What is the FDA product code for POLYURETHANE PROD. FOR I.V. NEEDLES?

The FDA product code for POLYURETHANE PROD. FOR I.V. NEEDLES is FPX.

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Other records listing Devon Industries, 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.

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK944114PHLEBOTOMY UNIT SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEM

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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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