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FDA 510(k)

STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE

K-Number: K974735 · 1998-06-24

ApplicantAaron Medical Industries
Decision Date1998-06-24
Product CodeJOS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE 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 1998-06-24 under 510(k) number K974735. 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 AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE?

STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE is a medical device that received FDA 510(k) clearance on 1998-06-24. The listed applicant is Aaron Medical Industries. The 510(k) number is K974735.

When did STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE receive FDA 510(k) clearance?

STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE received FDA 510(k) clearance on 1998-06-24, under 510(k) number K974735.

Who is the listed applicant for STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE?

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 AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE?

The FDA product code for STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE is JOS.

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Other records listing Aaron Medical Industries 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.

K062337MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTORK061307BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACKK060117BOVIE BUTTON REMOTE HAND SWITCHK022856BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATORK021817AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240VK020579AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03

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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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