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)

SURGICAL COLDLIGHT, AX8

K-Number: K770861 · 1977-06-17

ApplicantAffiliated Hospital Products, Inc.
Decision Date1977-06-17
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL COLDLIGHT, AX8 is the device name listed in this FDA 510(k) record. The listed applicant is Affiliated Hospital Products, Inc.. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770861. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL COLDLIGHT, AX8?

SURGICAL COLDLIGHT, AX8 is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Affiliated Hospital Products, Inc.. The 510(k) number is K770861.

When did SURGICAL COLDLIGHT, AX8 receive FDA 510(k) clearance?

SURGICAL COLDLIGHT, AX8 received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770861.

Who is the listed applicant for SURGICAL COLDLIGHT, AX8?

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

What is the FDA product code for SURGICAL COLDLIGHT, AX8?

The FDA product code for SURGICAL COLDLIGHT, AX8 is FTD.

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 Affiliated Hospital Products, 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.

K771942TILT 10, CATALOG #S-2600

Related Devices (Code: FTD)

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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLCK130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.

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.

↑