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)

HADGEL, 4 GRAM/SYRINGE

K-Number: K011544 · 2001-08-15

ApplicantSeikagaku Corp.
Decision Date2001-08-15
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HADGEL, 4 GRAM/SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Seikagaku Corp.. It received FDA 510(k) clearance on 2001-08-15 under 510(k) number K011544. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HADGEL, 4 GRAM/SYRINGE?

HADGEL, 4 GRAM/SYRINGE is a medical device that received FDA 510(k) clearance on 2001-08-15. The listed applicant is Seikagaku Corp.. The 510(k) number is K011544.

When did HADGEL, 4 GRAM/SYRINGE receive FDA 510(k) clearance?

HADGEL, 4 GRAM/SYRINGE received FDA 510(k) clearance on 2001-08-15, under 510(k) number K011544.

Who is the listed applicant for HADGEL, 4 GRAM/SYRINGE?

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

What is the FDA product code for HADGEL, 4 GRAM/SYRINGE?

The FDA product code for HADGEL, 4 GRAM/SYRINGE is LYA.

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

Related Devices (Code: LYA)

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.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

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.

↑