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FDA 510(k)

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE

K-Number: K862481 · 1986-07-23

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date1986-07-23
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 1986-07-23 under 510(k) number K862481. 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 CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE?

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE is a medical device that received FDA 510(k) clearance on 1986-07-23. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K862481.

When did CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE receive FDA 510(k) clearance?

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE received FDA 510(k) clearance on 1986-07-23, under 510(k) number K862481.

Who is the listed applicant for CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE?

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

What is the FDA product code for CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE?

The FDA product code for CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE is GDM.

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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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