FDA 510(k)

SI-14

K-Number: K801908 · 1980-11-12

Decision Date1980-11-12

Product CodeKDC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SI-14 is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Medical, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K801908. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-14?

SI-14 is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Kmi Medical, Inc.. The 510(k) number is K801908.

When did SI-14 receive FDA 510(k) clearance?

SI-14 received FDA 510(k) clearance on 1980-11-12, under 510(k) number K801908.

Who is the listed applicant for SI-14?

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

What is the FDA product code for SI-14?

The FDA product code for SI-14 is KDC.

Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstyles K920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, Inc.

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.