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FDA 510(k)

STAT

K-Number: K790893 · 1979-08-28

ApplicantVarian Assoc., Inc.
Decision Date1979-08-28
Product CodeHKP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STAT is the device name listed in this FDA 510(k) record. The listed applicant is Varian Assoc., Inc.. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K790893. The device is classified under product code HKP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT?

STAT is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Varian Assoc., Inc.. The 510(k) number is K790893.

When did STAT receive FDA 510(k) clearance?

STAT received FDA 510(k) clearance on 1979-08-28, under 510(k) number K790893.

Who is the listed applicant for STAT?

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

What is the FDA product code for STAT?

The FDA product code for STAT is HKP.

Related PubMed Literature

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.

PMID: 42825233Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.Neurosurgery practice ()PMID: 42815842Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.Regulatory toxicology and pharmacology : RTP ()PMID: 42714465Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.Indian dermatology online journal ()PMID: 42419560United States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends.World neurosurgery ()

Other records listing Varian Assoc., 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.

K000922PROTON VISIONK992762BRACHYVISION 6.0K992751SOMAVISIONK992753CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEMK990085MILLENNIUM MLC -120K980601VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER

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Related Devices (Code: HKP)

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.

K952558AARON VAC 2Aaron Medical IndustriesK950056THE GRIESHABER AXIAL CUTTERGrieshaber & Co.K950287UNIVIT PROBEMedical Instrument Development Laboratories, Inc.K896622VISITEC VITRECTOMY UNITVisitec Co.K890595MENTOR ANTERIOR SEGMENT VITRECTORMentor O & O, Inc.K832074CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRACooperVision, 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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