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FDA 510(k)

REFLEX(R) ECA

K-Number: K924929 · 1993-07-21

ApplicantRichard-Allan Medical
Decision Date1993-07-21
Product CodeHBT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFLEX(R) ECA is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K924929. The device is classified under product code HBT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLEX(R) ECA?

REFLEX(R) ECA is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Richard-Allan Medical. The 510(k) number is K924929.

When did REFLEX(R) ECA receive FDA 510(k) clearance?

REFLEX(R) ECA received FDA 510(k) clearance on 1993-07-21, under 510(k) number K924929.

Who is the listed applicant for REFLEX(R) ECA?

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

What is the FDA product code for REFLEX(R) ECA?

The FDA product code for REFLEX(R) ECA is HBT.

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 Richard-Allan Medical 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.

K942207REFLEX INS INSUFFLATION NEEDLEK935105REFLEX ESP WITH FINGER SWITCHESK933508REFLEX SDD SURGICAL STAPLERK933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)K924881REFLEX(R) ESPK905701RICHARD-ALLAN SHEET CLIP

View all 8 devices →

Related Devices (Code: HBT)

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.

K896262TITANIUM LIGATING CLIPSRichard-Allan Medical Ind., Inc.K862696TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEPDowns Surgical , Ltd.K800318DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLIEdward Weck, 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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