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)

NIOMED SURGICAL CAPS

K-Number: K955833 · 1996-03-15

ApplicantAmerasia Corp.
Decision Date1996-03-15
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIOMED SURGICAL CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Amerasia Corp.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K955833. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIOMED SURGICAL CAPS?

NIOMED SURGICAL CAPS is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Amerasia Corp.. The 510(k) number is K955833.

When did NIOMED SURGICAL CAPS receive FDA 510(k) clearance?

NIOMED SURGICAL CAPS received FDA 510(k) clearance on 1996-03-15, under 510(k) number K955833.

Who is the listed applicant for NIOMED SURGICAL CAPS?

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

What is the FDA product code for NIOMED SURGICAL CAPS?

The FDA product code for NIOMED SURGICAL CAPS is FYF.

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 Amerasia 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.

K954747NIOMED BARRIER GOWNSK954455NIOMED BOUFFANT CAPSK954454NIOMED SURGICAL HOODK952937NIOMED NON-SKID SHOE COVERSK952897NIOMED SHOE COVERS

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.K953879SURGEON'S CAPAmerican Threshold Industries, 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.

↑