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FDA 510(k)

INFILTUBE

K-Number: K925558 · 1994-03-04

ApplicantMedsurg Industries, Inc.
Decision Date1994-03-04
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INFILTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Medsurg Industries, Inc.. It received FDA 510(k) clearance on 1994-03-04 under 510(k) number K925558. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFILTUBE?

INFILTUBE is a medical device that received FDA 510(k) clearance on 1994-03-04. The listed applicant is Medsurg Industries, Inc.. The 510(k) number is K925558.

When did INFILTUBE receive FDA 510(k) clearance?

INFILTUBE received FDA 510(k) clearance on 1994-03-04, under 510(k) number K925558.

Who is the listed applicant for INFILTUBE?

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

What is the FDA product code for INFILTUBE?

The FDA product code for INFILTUBE is HIF.

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Other records listing Medsurg Industries, 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.

K920780MEDSURG INSERTION TRAYK940175MEDSURG STERILE O.R. TOWELSK934731MEDSURG STERILE IMAGING PRODUCTSK934971STERILE LAPAROTOMY SPONGESK920421MEDSURG MARSHMALLOW TRAYK920838MEDSURG CIRCUMCISION TRAY

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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