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FDA 510(k)

GALENICA'S DISPOSABLE ANOSCOPES

K-Number: K861017 · 1986-06-13

ApplicantGalenica Enterprises, Inc.
Decision Date1986-06-13
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GALENICA'S DISPOSABLE ANOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Galenica Enterprises, Inc.. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K861017. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALENICA'S DISPOSABLE ANOSCOPES?

GALENICA'S DISPOSABLE ANOSCOPES is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is Galenica Enterprises, Inc.. The 510(k) number is K861017.

When did GALENICA'S DISPOSABLE ANOSCOPES receive FDA 510(k) clearance?

GALENICA'S DISPOSABLE ANOSCOPES received FDA 510(k) clearance on 1986-06-13, under 510(k) number K861017.

Who is the listed applicant for GALENICA'S DISPOSABLE ANOSCOPES?

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

What is the FDA product code for GALENICA'S DISPOSABLE ANOSCOPES?

The FDA product code for GALENICA'S DISPOSABLE ANOSCOPES is FER.

Related Clinical Trials

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Other records listing Galenica Enterprises, 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.

K923656LIGHTING SOURCE SYSTEMK896383DISPOSABLE EXTERNAL CLAMPSK883283DISPOSABLE AMNIOTOMEK841909VAGINAL SPECULUM - DISPOSABLE

Related Devices (Code: FER)

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.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K242668Gastro Concepts Air AssistGastro Concepts, LLCK230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.K133687THD N-ANO ANOSCOPEThd Spa

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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