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)

TRAY, CATHETERIZATION W/FOLEY, STERILE

K-Number: K770797 · 1977-07-11

ApplicantLukens Corp.
Decision Date1977-07-11
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRAY, CATHETERIZATION W/FOLEY, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Lukens Corp.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K770797. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAY, CATHETERIZATION W/FOLEY, STERILE?

TRAY, CATHETERIZATION W/FOLEY, STERILE is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Lukens Corp.. The 510(k) number is K770797.

When did TRAY, CATHETERIZATION W/FOLEY, STERILE receive FDA 510(k) clearance?

TRAY, CATHETERIZATION W/FOLEY, STERILE received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770797.

Who is the listed applicant for TRAY, CATHETERIZATION W/FOLEY, STERILE?

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

What is the FDA product code for TRAY, CATHETERIZATION W/FOLEY, STERILE?

The FDA product code for TRAY, CATHETERIZATION W/FOLEY, STERILE is FRG.

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 Lukens 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.

K880230SIXALYZERK800102STANFORD STERILE LAP SPONGESK792471STANFORD STERILE LAP SPONGESK791495LUKENS BONE WAX (GAMMA RADIATION)K770795SHAVE PREP SETK770799TRAY, IRRIGATION, STERILE, BASIC

View all 11 devices →

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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.

↑