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FDA 510(k)

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA

K-Number: K852014 · 1985-08-07

ApplicantEffner and Spreine Co.
Decision Date1985-08-07
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA is the device name listed in this FDA 510(k) record. The listed applicant is Effner and Spreine Co.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K852014. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA?

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Effner and Spreine Co.. The 510(k) number is K852014.

When did EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA receive FDA 510(k) clearance?

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA received FDA 510(k) clearance on 1985-08-07, under 510(k) number K852014.

Who is the listed applicant for EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA?

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

What is the FDA product code for EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA?

The FDA product code for EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA is KOA.

Related Clinical Trials

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.

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Other records listing Effner and Spreine Co. 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.

K875260EFFNER CAUTERY INSTRUMENTSK874755EFFNER FE-EX* OROGASTRICK872480KAHN-TACT U.S.A., EFF LARYNGOSCOPE

Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, 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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