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FDA 510(k)

ENDOSCOPIC ELECTRODE

K-Number: K912656 · 1991-09-16

ApplicantApplied Urology, Inc.
Decision Date1991-09-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC ELECTRODE 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 1991-09-16 under 510(k) number K912656. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC ELECTRODE?

ENDOSCOPIC ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-09-16. The listed applicant is Applied Urology, Inc.. The 510(k) number is K912656.

When did ENDOSCOPIC ELECTRODE receive FDA 510(k) clearance?

ENDOSCOPIC ELECTRODE received FDA 510(k) clearance on 1991-09-16, under 510(k) number K912656.

Who is the listed applicant for ENDOSCOPIC ELECTRODE?

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 ENDOSCOPIC ELECTRODE?

The FDA product code for ENDOSCOPIC ELECTRODE is GEI.

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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 STENTK915219URETHRAL ELECTRODE SHEATHK912093DISPOSABLE ASPIRATION IRRIGATION SYSTEMK920030SURESEAL ENDOSCOPIC VALVE

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Related Devices (Code: GEI)

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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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