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FDA 510(k)

ALLEN UNIVERSAL STIRRUP

K-Number: K860177 · 1986-02-11

ApplicantEdgewater Medical Equipment Systems
Decision Date1986-02-11
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEN UNIVERSAL STIRRUP is the device name listed in this FDA 510(k) record. The listed applicant is Edgewater Medical Equipment Systems. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K860177. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEN UNIVERSAL STIRRUP?

ALLEN UNIVERSAL STIRRUP is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Edgewater Medical Equipment Systems. The 510(k) number is K860177.

When did ALLEN UNIVERSAL STIRRUP receive FDA 510(k) clearance?

ALLEN UNIVERSAL STIRRUP received FDA 510(k) clearance on 1986-02-11, under 510(k) number K860177.

Who is the listed applicant for ALLEN UNIVERSAL STIRRUP?

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

What is the FDA product code for ALLEN UNIVERSAL STIRRUP?

The FDA product code for ALLEN UNIVERSAL STIRRUP is BWN.

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 Edgewater Medical Equipment Systems 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.

K873370ALLEN MALLEABLE ANESTHESIA SCREENK872900THE PORTABLE ORDERLY

Related Devices (Code: BWN)

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.

K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, 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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