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FDA 510(k)

SPINAL NEEDLE

K-Number: K882073 · 1988-07-18

ApplicantKarlin Technology, Inc.
Decision Date1988-07-18
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K882073. 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 SPINAL NEEDLE?

SPINAL NEEDLE is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882073.

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

SPINAL NEEDLE received FDA 510(k) clearance on 1988-07-18, under 510(k) number K882073.

Who is the listed applicant for SPINAL NEEDLE?

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

What is the FDA product code for SPINAL NEEDLE?

The FDA product code for SPINAL NEEDLE is GDM.

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Other records listing Karlin Technology, 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893201BONE PLATEK893203BONE SCREWK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882520SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS

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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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