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)

NAVIGATOR (STYLET) 2006

K-Number: K972521 · 1997-10-01

ApplicantSil-Med Corp.
Decision Date1997-10-01
Product CodeGAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR (STYLET) 2006 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 1997-10-01 under 510(k) number K972521. The device is classified under product code GAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR (STYLET) 2006?

NAVIGATOR (STYLET) 2006 is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Sil-Med Corp.. The 510(k) number is K972521.

When did NAVIGATOR (STYLET) 2006 receive FDA 510(k) clearance?

NAVIGATOR (STYLET) 2006 received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972521.

Who is the listed applicant for NAVIGATOR (STYLET) 2006?

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 NAVIGATOR (STYLET) 2006?

The FDA product code for NAVIGATOR (STYLET) 2006 is GAH.

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.

K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IIK961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINK961295SAPPHIRE 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: GAH)

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.

K110355VENX REVOLUTIONVenx, LLCK000932ARACHNOPHLEBECTOMY NEEDLEAdvanced Medical Products, Inc.K970306MARKMAN TEMPLATE SYSTEMBarry Markman, M.D.K972918RAPID FIRE HAIR IMPLANTER CAROUSELApex Medical Products, LLCK952737CALVITRON HAIR TRANSPLANT SYSTEMMedicamat S.A.K770970HAIR TRANSPLANT PUNCH, MULTIPLHPadgett Instruments, 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.

↑