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FDA 510(k)

URETHRAL ELECTRODE SHEATH

K-Number: K915219 · 1992-07-23

ApplicantApplied Urology, Inc.
Decision Date1992-07-23
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL ELECTRODE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Applied Urology, Inc.. It received FDA 510(k) clearance on 1992-07-23 under 510(k) number K915219. 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 URETHRAL ELECTRODE SHEATH?

URETHRAL ELECTRODE SHEATH is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Applied Urology, Inc.. The 510(k) number is K915219.

When did URETHRAL ELECTRODE SHEATH receive FDA 510(k) clearance?

URETHRAL ELECTRODE SHEATH received FDA 510(k) clearance on 1992-07-23, under 510(k) number K915219.

Who is the listed applicant for URETHRAL ELECTRODE SHEATH?

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

What is the FDA product code for URETHRAL ELECTRODE SHEATH?

The FDA product code for URETHRAL ELECTRODE SHEATH is FAS.

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Other records listing Applied Urology, 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.

K921838ACUCISE URETERAL CUTTING CATHETERK925282UROLOGICAL CATHETER AND ACCESSORIESK920695URETERAL STENTK912093DISPOSABLE ASPIRATION IRRIGATION SYSTEMK920030SURESEAL ENDOSCOPIC VALVEK912656ENDOSCOPIC ELECTRODE

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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

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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