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)

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN

K-Number: K961194 · 1996-08-08

ApplicantSil-Med Corp.
Decision Date1996-08-08
Product CodeGBW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Sil-Med Corp.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K961194. The device is classified under product code GBW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Sil-Med Corp.. The 510(k) number is K961194.

When did ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN receive FDA 510(k) clearance?

ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN received FDA 510(k) clearance on 1996-08-08, under 510(k) number K961194.

Who is the listed applicant for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

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

What is the FDA product code for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN?

The FDA product code for ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN is GBW.

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 Sil-Med 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.

K972521NAVIGATOR (STYLET) 2006K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IIK961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARK960099PENROSE DRAIN MODELS 6001 - 6007K955463GRIP-A-BOOTSK942709MEDIASTINAL SILICONE DRAINS

View all 29 devices →

Related Devices (Code: GBW)

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.

K992904MINI-PORTTaut, Inc.K992907INTRADUCERTaut, Inc.K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.K942709MEDIASTINAL SILICONE DRAINSSil-Med Corp.K933510ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETERSherwood Medical Co.

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.

↑