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)

SPIRABRUSH CX BIOPSY INSTRUMENT

K-Number: K011488 · 2002-02-22

ApplicantTrylon Corp.
Decision Date2002-02-22
Product CodeHFB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPIRABRUSH CX BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Corp.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K011488. The device is classified under product code HFB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRABRUSH CX BIOPSY INSTRUMENT?

SPIRABRUSH CX BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Trylon Corp.. The 510(k) number is K011488.

When did SPIRABRUSH CX BIOPSY INSTRUMENT receive FDA 510(k) clearance?

SPIRABRUSH CX BIOPSY INSTRUMENT received FDA 510(k) clearance on 2002-02-22, under 510(k) number K011488.

Who is the listed applicant for SPIRABRUSH CX BIOPSY INSTRUMENT?

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

What is the FDA product code for SPIRABRUSH CX BIOPSY INSTRUMENT?

The FDA product code for SPIRABRUSH CX BIOPSY INSTRUMENT is HFB.

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 Trylon 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.

K033033VIZILITE-BLUE ORAL EXAM KITK012070ORALLITE COMPREHENSIVE EXAM TRAYK003995SPECULITE/ORALLITEK963391SPECULITEK955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYK953364SPECULITE

View all 7 devices →

Related Devices (Code: HFB)

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.

K944444CIT BIOPSY PUNCHESChirurgische InstrumenteK930773SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPSSymbiosis Corp.K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYMahe-MedizintechnikK926595OWENS BIOPSY FORCEPSOwens Industries, Inc.K926527ROTO FIT BIOPSY FORCEPSThomasville Medical Assoc.K926538TISCHLER BIOPSY FORCEPSThomasville Medical Assoc.

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.

↑