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FDA 510(k)

REFLEX ONE STAPLE EXTRACTOR

K-Number: K830867 · 1983-04-12

ApplicantRichard-Allan Medical Ind., Inc.
Decision Date1983-04-12
Product Code
DecisionSubstantially Equivalent

Device Summary

REFLEX ONE STAPLE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical Ind., Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830867. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLEX ONE STAPLE EXTRACTOR?

REFLEX ONE STAPLE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Richard-Allan Medical Ind., Inc.. The 510(k) number is K830867.

When did REFLEX ONE STAPLE EXTRACTOR receive FDA 510(k) clearance?

REFLEX ONE STAPLE EXTRACTOR received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830867.

Who is the listed applicant for REFLEX ONE STAPLE EXTRACTOR?

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

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Other records listing Richard-Allan Medical Ind., 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.

K931879REFLEX HTRK924200REFLEX(R) ESCK926297REFLEX ESIK924761STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELDK900566RICHARD-ALLAN VESSEL LOOPSK896262TITANIUM LIGATING CLIPS

View all 33 devices →

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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