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)

DAYSTAR SELECTRA & SELECTRA/ORBITER

K-Number: K780666 · 1978-04-27

ApplicantCastle Co.
Decision Date1978-04-27
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DAYSTAR SELECTRA & SELECTRA/ORBITER is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1978-04-27 under 510(k) number K780666. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAYSTAR SELECTRA & SELECTRA/ORBITER?

DAYSTAR SELECTRA & SELECTRA/ORBITER is a medical device that received FDA 510(k) clearance on 1978-04-27. The listed applicant is Castle Co.. The 510(k) number is K780666.

When did DAYSTAR SELECTRA & SELECTRA/ORBITER receive FDA 510(k) clearance?

DAYSTAR SELECTRA & SELECTRA/ORBITER received FDA 510(k) clearance on 1978-04-27, under 510(k) number K780666.

Who is the listed applicant for DAYSTAR SELECTRA & SELECTRA/ORBITER?

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

What is the FDA product code for DAYSTAR SELECTRA & SELECTRA/ORBITER?

The FDA product code for DAYSTAR SELECTRA & SELECTRA/ORBITER is FSY.

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 Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK833074CASTLE TEC-TEST S.M.A.R.T. PACKK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AER

View all 21 devices →

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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.

↑