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)

SURGITEK(R) EXTERNAL FILL PORT

K-Number: K894495 · 1990-01-17

ApplicantSurgitek
Decision Date1990-01-17
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SURGITEK(R) EXTERNAL FILL PORT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1990-01-17 under 510(k) number K894495. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK(R) EXTERNAL FILL PORT?

SURGITEK(R) EXTERNAL FILL PORT is a medical device that received FDA 510(k) clearance on 1990-01-17. The listed applicant is Surgitek. The 510(k) number is K894495.

When did SURGITEK(R) EXTERNAL FILL PORT receive FDA 510(k) clearance?

SURGITEK(R) EXTERNAL FILL PORT received FDA 510(k) clearance on 1990-01-17, under 510(k) number K894495.

Who is the listed applicant for SURGITEK(R) EXTERNAL FILL PORT?

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

What is the FDA product code for SURGITEK(R) EXTERNAL FILL PORT?

The FDA product code for SURGITEK(R) EXTERNAL FILL PORT is LCJ.

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 Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

View all 29 devices →

Related Devices (Code: LCJ)

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.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, 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.

↑