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FDA 510(k)

HYPODERMIC NEEDLES, SINGLE LUMEN

K-Number: K911397 · 1991-05-20

ApplicantPopper & Sons, Inc.
Decision Date1991-05-20
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLES, SINGLE LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Popper & Sons, Inc.. It received FDA 510(k) clearance on 1991-05-20 under 510(k) number K911397. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPODERMIC NEEDLES, SINGLE LUMEN?

HYPODERMIC NEEDLES, SINGLE LUMEN is a medical device that received FDA 510(k) clearance on 1991-05-20. The listed applicant is Popper & Sons, Inc.. The 510(k) number is K911397.

When did HYPODERMIC NEEDLES, SINGLE LUMEN receive FDA 510(k) clearance?

HYPODERMIC NEEDLES, SINGLE LUMEN received FDA 510(k) clearance on 1991-05-20, under 510(k) number K911397.

Who is the listed applicant for HYPODERMIC NEEDLES, SINGLE LUMEN?

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

What is the FDA product code for HYPODERMIC NEEDLES, SINGLE LUMEN?

The FDA product code for HYPODERMIC NEEDLES, SINGLE LUMEN is FCG.

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Other records listing Popper & Sons, 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.

K843830J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPIK843690ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLEK842406WESCOTT TYPE BIOPSY NEEDLEK841300ANTRUM NEEDLE-WOLF TYPEK841301GARDNER TYPE BONE MARROW NEEDLEK841299BIERMAN BIOPSY NEEDLE

View all 8 devices →

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, 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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