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FDA 510(k)

ENDO-NEEDLE INSTRUMENT

K-Number: K936207 · 1994-06-16

ApplicantGerard Medical, Inc.
Decision Date1994-06-16
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDO-NEEDLE INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical, Inc.. It received FDA 510(k) clearance on 1994-06-16 under 510(k) number K936207. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-NEEDLE INSTRUMENT?

ENDO-NEEDLE INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-06-16. The listed applicant is Gerard Medical, Inc.. The 510(k) number is K936207.

When did ENDO-NEEDLE INSTRUMENT receive FDA 510(k) clearance?

ENDO-NEEDLE INSTRUMENT received FDA 510(k) clearance on 1994-06-16, under 510(k) number K936207.

Who is the listed applicant for ENDO-NEEDLE INSTRUMENT?

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

What is the FDA product code for ENDO-NEEDLE INSTRUMENT?

The FDA product code for ENDO-NEEDLE INSTRUMENT is GDM.

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Other records listing Gerard Medical, 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.

K974533TRIMPORTK972555CATHETER TUNNELERK945060HERNIA MESH INTRODUCTION SYSTEM

Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.K923872BONE MARROW BIOPSY SYSTEMThe Straumann Co.

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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