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FDA 510(k)

STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE

K-Number: K971187 · 1997-05-05

ApplicantAaron Medical Industries
Decision Date1997-05-05
Product CodeJOS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Aaron Medical Industries. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K971187. The device is classified under product code JOS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE?

STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Aaron Medical Industries. The 510(k) number is K971187.

When did STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE receive FDA 510(k) clearance?

STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K971187.

Who is the listed applicant for STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE?

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

What is the FDA product code for STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE?

The FDA product code for STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE is JOS.

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Other records listing Aaron Medical Industries as applicant

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Related Devices (Code: JOS)

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.

K161600Resection ElectrodesOlympus Winter & Ibe GmbHK050923LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATORConmed LinvatecK012684REPROCESSED ELECTROSURGICAL ELECTRODESterilmed, Inc.K011515MEDLINE GROUNDING PADMedline Industries, Inc.K003403ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999Highland / Marietta, Inc.K000333STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MODTriad Surgical Technologies, Inc.

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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