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FDA 510(k)

BENDEREV PROTECT-A-PASS NEEDLE

K-Number: K921228 · 1992-09-14

ApplicantEimark Labs, Inc.
Decision Date1992-09-14
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BENDEREV PROTECT-A-PASS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Eimark Labs, Inc.. It received FDA 510(k) clearance on 1992-09-14 under 510(k) number K921228. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENDEREV PROTECT-A-PASS NEEDLE?

BENDEREV PROTECT-A-PASS NEEDLE is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is Eimark Labs, Inc.. The 510(k) number is K921228.

When did BENDEREV PROTECT-A-PASS NEEDLE receive FDA 510(k) clearance?

BENDEREV PROTECT-A-PASS NEEDLE received FDA 510(k) clearance on 1992-09-14, under 510(k) number K921228.

Who is the listed applicant for BENDEREV PROTECT-A-PASS NEEDLE?

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

What is the FDA product code for BENDEREV PROTECT-A-PASS NEEDLE?

The FDA product code for BENDEREV PROTECT-A-PASS NEEDLE is KOA.

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Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, Inc.

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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