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)

SPLINTS(ALL TYPE)

K-Number: K852558 · 1985-07-02

ApplicantThe Huxley Instrument Corp.
Decision Date1985-07-02
Product CodeFYH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPLINTS(ALL TYPE) is the device name listed in this FDA 510(k) record. The listed applicant is The Huxley Instrument Corp.. It received FDA 510(k) clearance on 1985-07-02 under 510(k) number K852558. The device is classified under product code FYH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLINTS(ALL TYPE)?

SPLINTS(ALL TYPE) is a medical device that received FDA 510(k) clearance on 1985-07-02. The listed applicant is The Huxley Instrument Corp.. The 510(k) number is K852558.

When did SPLINTS(ALL TYPE) receive FDA 510(k) clearance?

SPLINTS(ALL TYPE) received FDA 510(k) clearance on 1985-07-02, under 510(k) number K852558.

Who is the listed applicant for SPLINTS(ALL TYPE)?

The FDA 510(k) record lists The Huxley Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPLINTS(ALL TYPE)?

The FDA product code for SPLINTS(ALL TYPE) is FYH.

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 The Huxley Instrument Corp. 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.

K852721BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420K852993BONE RONGEURSK853016STILLE ANGULAR RONGEUR, 8-3/4 SS 410K853015SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420K852716TAYLOR PERCUSSION HAMMER SS 410 OR 420K852728KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS

View all 53 devices →

Related Devices (Code: FYH)

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.

K925145TRACE MODEL #'S 840, 841, 842, 845Trace Medical Equipment, Inc.K924984SPECIALIST(R) WALKERJohnson & Johnson Orthopaedics, Inc.K895092KUT-SHIELDKut-Guard, Inc.K843400HYDRO-SPLINT A SPONGE-COMPRESS DRESSCompression Splint Products, Inc.K821693J & J DIP WATER ADDITIVEJohnson & Johnson Professionals, Inc.K802522DELTA-LITE CASTING TAPE & SPLINTSJohnson & Johnson Professionals, 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.

↑