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)

NITTO SURGICAL NON-WOVEN TAPE ST-320

K-Number: K853646 · 1985-09-19

ApplicantNitto Denko America, Inc.
Decision Date1985-09-19
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITTO SURGICAL NON-WOVEN TAPE ST-320 is the device name listed in this FDA 510(k) record. The listed applicant is Nitto Denko America, Inc.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K853646. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITTO SURGICAL NON-WOVEN TAPE ST-320?

NITTO SURGICAL NON-WOVEN TAPE ST-320 is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Nitto Denko America, Inc.. The 510(k) number is K853646.

When did NITTO SURGICAL NON-WOVEN TAPE ST-320 receive FDA 510(k) clearance?

NITTO SURGICAL NON-WOVEN TAPE ST-320 received FDA 510(k) clearance on 1985-09-19, under 510(k) number K853646.

Who is the listed applicant for NITTO SURGICAL NON-WOVEN TAPE ST-320?

The FDA 510(k) record lists Nitto Denko America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITTO SURGICAL NON-WOVEN TAPE ST-320?

The FDA product code for NITTO SURGICAL NON-WOVEN TAPE ST-320 is KGX.

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 Nitto Denko America, 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.

K871441ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODEK853647NITTO SURGICAL PAPER TAPE ST-310K853645NITTO SURGICAL CLOTH TAPE ST-330K853644NITTO SURGICAL PLASTIC TAPE ST-356

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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.

↑