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FDA 510(k)

ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999

K-Number: K003403 · 2001-05-07

ApplicantHighland / Marietta, Inc.
Decision Date2001-05-07
Product CodeJOS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 is the device name listed in this FDA 510(k) record. The listed applicant is Highland / Marietta, Inc.. It received FDA 510(k) clearance on 2001-05-07 under 510(k) number K003403. 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 ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999?

ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 is a medical device that received FDA 510(k) clearance on 2001-05-07. The listed applicant is Highland / Marietta, Inc.. The 510(k) number is K003403.

When did ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 receive FDA 510(k) clearance?

ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 received FDA 510(k) clearance on 2001-05-07, under 510(k) number K003403.

Who is the listed applicant for ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999?

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

What is the FDA product code for ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999?

The FDA product code for ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 is JOS.

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Other records listing Highland / Marietta, 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.

K003405ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO

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.K000333STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MODTriad Surgical Technologies, Inc.K993885ULTRABLATOR ELECTRODELinvatec Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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