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FDA 510(k)

KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET

K-Number: K123822 · 2013-09-27

ApplicantHk Surgical, Inc.
Decision Date2013-09-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Hk Surgical, Inc.. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K123822. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET?

KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Hk Surgical, Inc.. The 510(k) number is K123822.

When did KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET receive FDA 510(k) clearance?

KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET received FDA 510(k) clearance on 2013-09-27, under 510(k) number K123822.

Who is the listed applicant for KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET?

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

What is the FDA product code for KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET?

The FDA product code for KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET is FRN.

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 Hk Surgical, 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.

K032802HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-IIIK031432KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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