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)

PRILANE

K-Number: K981524 · 1998-07-10

ApplicantGresco Products, Inc.
Decision Date1998-07-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRILANE is the device name listed in this FDA 510(k) record. The listed applicant is Gresco Products, Inc.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K981524. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRILANE?

PRILANE is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Gresco Products, Inc.. The 510(k) number is K981524.

When did PRILANE receive FDA 510(k) clearance?

PRILANE received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981524.

Who is the listed applicant for PRILANE?

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

What is the FDA product code for PRILANE?

The FDA product code for PRILANE is EIH.

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 Gresco Products, 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.

K913405KAR-D-TEKK910813MET-ETCHK910803ENAMEL ETCHING GELK901973CP-3 DENTAL POLISHING MATERIALK854495GRESCO N.P. DENTAL ALLOYK854494CERAM-ETCH

View all 7 devices →

Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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.

↑