Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIGIKIT NONPNEUMATIC TOURNIQUET

K-Number: K860095 · 1986-01-24

ApplicantOrthofab, Inc.
Decision Date1986-01-24
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIGIKIT NONPNEUMATIC TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Orthofab, Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K860095. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIKIT NONPNEUMATIC TOURNIQUET?

DIGIKIT NONPNEUMATIC TOURNIQUET is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Orthofab, Inc.. The 510(k) number is K860095.

When did DIGIKIT NONPNEUMATIC TOURNIQUET receive FDA 510(k) clearance?

DIGIKIT NONPNEUMATIC TOURNIQUET received FDA 510(k) clearance on 1986-01-24, under 510(k) number K860095.

Who is the listed applicant for DIGIKIT NONPNEUMATIC TOURNIQUET?

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

What is the FDA product code for DIGIKIT NONPNEUMATIC TOURNIQUET?

The FDA product code for DIGIKIT NONPNEUMATIC TOURNIQUET is KCY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Orthofab, 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.

K962565POWERED WHEELCHAIRK952675ORTHOFAB WHEELCHAIRK950904ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)K950903ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)K884812KARMA-RS, KARMA-FS WHEELCHAIRSK852661APOLLO STERILE BLADES

View all 7 devices →

Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, 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.

↑