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FDA 510(k)

RETROBULBAR NEEDLE

K-Number: K873848 · 1987-10-23

ApplicantHealthtek, Inc.
Decision Date1987-10-23
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RETROBULBAR NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Healthtek, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873848. 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 RETROBULBAR NEEDLE?

RETROBULBAR NEEDLE is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is Healthtek, Inc.. The 510(k) number is K873848.

When did RETROBULBAR NEEDLE receive FDA 510(k) clearance?

RETROBULBAR NEEDLE received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873848.

Who is the listed applicant for RETROBULBAR NEEDLE?

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

What is the FDA product code for RETROBULBAR NEEDLE?

The FDA product code for RETROBULBAR NEEDLE is GDM.

Related Clinical Trials

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.

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Other records listing Healthtek, 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.

K923448EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEGK913985TRANSFER-AID(TM)K913608SNAPPERK881590ADFUSE(TM)K874495ADCOMP 4000 HP SYSTEMK860610ADCOMP

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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.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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