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FDA 510(k)

PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

K-Number: K915068 · 1992-02-06

ApplicantAmerican Medical Mfg., Inc.
Decision Date1992-02-06
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Mfg., Inc.. It received FDA 510(k) clearance on 1992-02-06 under 510(k) number K915068. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER?

PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER is a medical device that received FDA 510(k) clearance on 1992-02-06. The listed applicant is American Medical Mfg., Inc.. The 510(k) number is K915068.

When did PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER receive FDA 510(k) clearance?

PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER received FDA 510(k) clearance on 1992-02-06, under 510(k) number K915068.

Who is the listed applicant for PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER?

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

What is the FDA product code for PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER?

The FDA product code for PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER is FTA.

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 American Medical Mfg., 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.

K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELLK961454AMMI MAGNI-GUARDK915066DISPOSABLE SKIN MARKERK915064DISPOSABLE CAUTERY ABRASIVE PADK915065I.V.IRRIGATION POLE

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, 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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