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FDA 510(k)

PYELOSCOPE SYSTEM

K-Number: K770729 · 1977-04-28

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1977-04-28
Product CodeFGA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PYELOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1977-04-28 under 510(k) number K770729. The device is classified under product code FGA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYELOSCOPE SYSTEM?

PYELOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1977-04-28. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K770729.

When did PYELOSCOPE SYSTEM receive FDA 510(k) clearance?

PYELOSCOPE SYSTEM received FDA 510(k) clearance on 1977-04-28, under 510(k) number K770729.

Who is the listed applicant for PYELOSCOPE SYSTEM?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYELOSCOPE SYSTEM?

The FDA product code for PYELOSCOPE SYSTEM is FGA.

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Other records listing Richard Wolf Medical Instruments Corp. as applicant

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Related Devices (Code: FGA)

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.

K232370Percutaneous Nephroscope SystemKarl Storz SE & CO. KGK151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbHK072594GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEMGyrus Acmi, Inc.K994223NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20Richard Wolf Medical Instruments Corp.K950433KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.K940594KARL STORZ ADULT & PEDIATRIC NEPHROSCOPEKARL STORZ Endoscopy-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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