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FDA 510(k)

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE

K-Number: K895594 · 1989-10-06

ApplicantGo Medical Industries Pty. , Ltd.
Decision Date1989-10-06
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Go Medical Industries Pty. , Ltd.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895594. 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 SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE?

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Go Medical Industries Pty. , Ltd.. The 510(k) number is K895594.

When did SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE receive FDA 510(k) clearance?

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895594.

Who is the listed applicant for SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE?

The FDA 510(k) record lists Go Medical Industries Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE?

The FDA product code for SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE is GDM.

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Other records listing Go Medical Industries Pty. , Ltd. 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.

K011055THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADSK002803THE O'NEIL STERILE FIELD URINARY CATHETER KITK000263GO MEDICAL BALLOON INFUSION SYSTEMK910007SPRINGFUSOR 10RK900336V SETK890400MODIFIED URINARY CATHETER INTRODUCER (UCI)

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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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