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FDA 510(k)

GYNECOLOGICAL CYSTO/URETHROSCOPE

K-Number: K800913 · 1980-05-14

ApplicantKli
Decision Date1980-05-14
Product CodeFGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GYNECOLOGICAL CYSTO/URETHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Kli. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800913. The device is classified under product code FGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECOLOGICAL CYSTO/URETHROSCOPE?

GYNECOLOGICAL CYSTO/URETHROSCOPE is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Kli. The 510(k) number is K800913.

When did GYNECOLOGICAL CYSTO/URETHROSCOPE receive FDA 510(k) clearance?

GYNECOLOGICAL CYSTO/URETHROSCOPE received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800913.

Who is the listed applicant for GYNECOLOGICAL CYSTO/URETHROSCOPE?

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

What is the FDA product code for GYNECOLOGICAL CYSTO/URETHROSCOPE?

The FDA product code for GYNECOLOGICAL CYSTO/URETHROSCOPE is FGC.

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Other records listing Kli 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.

K800822CO2 CYSTOSCOPY/URETHROSCOPY CONSOLEK781913INSUFFALATOR LAPARAOSCOPICK781109FORCEPS, ELECTROSURGICALK781089ONE INCISION BI-POLAR ELECTRO. FORCEPSK780955SCISSORS, HOOK, ELECTROSURGICALK780954SCISSORS, HOOK, ELECTROSURGICAL

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Related Devices (Code: FGC)

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.

K091600DIRECTVISION GUIDE SYSTEMPercuvision, LLCK945907KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURESKARL 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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