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FDA 510(k)

INTRODUCER NEEDLES

K-Number: K910641 · 1991-04-29

ApplicantAkcess Medical Products, Inc.
Decision Date1991-04-29
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTRODUCER NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K910641. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCER NEEDLES?

INTRODUCER NEEDLES is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K910641.

When did INTRODUCER NEEDLES receive FDA 510(k) clearance?

INTRODUCER NEEDLES received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910641.

Who is the listed applicant for INTRODUCER NEEDLES?

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

What is the FDA product code for INTRODUCER NEEDLES?

The FDA product code for INTRODUCER NEEDLES is KOC.

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Related Devices (Code: KOC)

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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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