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FDA 510(k)

GYNEX EXTENDED REACH NEEDLE

K-Number: K980238 · 1998-08-21

ApplicantGynex Corp.
Decision Date1998-08-21
Product CodeHEE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNEX EXTENDED REACH NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Gynex Corp.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K980238. The device is classified under product code HEE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNEX EXTENDED REACH NEEDLE?

GYNEX EXTENDED REACH NEEDLE is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Gynex Corp.. The 510(k) number is K980238.

When did GYNEX EXTENDED REACH NEEDLE receive FDA 510(k) clearance?

GYNEX EXTENDED REACH NEEDLE received FDA 510(k) clearance on 1998-08-21, under 510(k) number K980238.

Who is the listed applicant for GYNEX EXTENDED REACH NEEDLE?

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

What is the FDA product code for GYNEX EXTENDED REACH NEEDLE?

The FDA product code for GYNEX EXTENDED REACH NEEDLE is HEE.

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 Gynex Corp. 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.

K061306CO-1000 COLPOSCOPE, MULTIPLEK982739GYNEX ELECTRODESK980237GYNEX ENDOSPECULUMK980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

Related Devices (Code: HEE)

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.

K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGERocket Medical PlcK021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEAvid Medical, Inc.K983897CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.K973671ENDOCERVICAL BLOCK NEEDLEA & A Medical, Inc.K954718ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGEEllman Intl., 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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