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)

REPROCESSED COLD BIOPSY FORCEPS

K-Number: K042648 · 2005-07-20

ApplicantSterilmed, Inc.
Decision Date2005-07-20
Product CodeNON
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REPROCESSED COLD BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2005-07-20 under 510(k) number K042648. The device is classified under product code NON. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED COLD BIOPSY FORCEPS?

REPROCESSED COLD BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Sterilmed, Inc.. The 510(k) number is K042648.

When did REPROCESSED COLD BIOPSY FORCEPS receive FDA 510(k) clearance?

REPROCESSED COLD BIOPSY FORCEPS received FDA 510(k) clearance on 2005-07-20, under 510(k) number K042648.

Who is the listed applicant for REPROCESSED COLD BIOPSY FORCEPS?

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

What is the FDA product code for REPROCESSED COLD BIOPSY FORCEPS?

The FDA product code for REPROCESSED COLD BIOPSY FORCEPS is NON.

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 Sterilmed, 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.

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterK190478Reprocessed ViewFlex™ Xtra ICE CatheterK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyK182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisK161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

View all 60 devices →

Related Devices (Code: NON)

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.

K042659MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPSMedisissK042594VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPSVanguard Medical Concepts, 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.

↑