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FDA 510(k)

ACMI RIGI-FLEX NEPHORSCOPE

K-Number: K791182 · 1979-07-30

ApplicantAmerican Cystocope Makers, Inc.
Decision Date1979-07-30
Product CodeFGA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACMI RIGI-FLEX NEPHORSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K791182. 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 ACMI RIGI-FLEX NEPHORSCOPE?

ACMI RIGI-FLEX NEPHORSCOPE is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K791182.

When did ACMI RIGI-FLEX NEPHORSCOPE receive FDA 510(k) clearance?

ACMI RIGI-FLEX NEPHORSCOPE received FDA 510(k) clearance on 1979-07-30, under 510(k) number K791182.

Who is the listed applicant for ACMI RIGI-FLEX NEPHORSCOPE?

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

What is the FDA product code for ACMI RIGI-FLEX NEPHORSCOPE?

The FDA product code for ACMI RIGI-FLEX NEPHORSCOPE is FGA.

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Other records listing American Cystocope Makers, 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.

K832040STERILE FLUID PRODUCING UNIT #EP550K812637ACMI BIPOLAR HEMOSTATIC SOURCEK811218ACMI ASPIRATOR KIT #8808K803214ACMI BIPOLAR HEMOSTATIC ELECTRODEK770754DUODENOSCOPE, MOLEL TX-6K760822MODEL TX-8 PANENDOSCOPE

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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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