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FDA 510(k)

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

K-Number: K053322 · 2006-01-06

ApplicantRoei Medical Technologies, Ltd.
Decision Date2006-01-06
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Roei Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K053322. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS?

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Roei Medical Technologies, Ltd.. The 510(k) number is K053322.

When did MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS receive FDA 510(k) clearance?

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053322.

Who is the listed applicant for MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS?

The FDA 510(k) record lists Roei Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS?

The FDA product code for MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS is FAS.

Related Clinical Trials

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Other records listing Roei Medical Technologies, Ltd. 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.

K050910ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS

Related Devices (Code: FAS)

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.

K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )Dornier Medtech America Inc (Dmta)K250522Multi4 SystemMulti4 Medical ABK240504PLASMA EDGE SystemLamidey Noury MedicalK213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie InnovationK210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbHK210394Electrosurgical accessoryDornier Medtech America, Inc.

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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