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)

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING

K-Number: K071087 · 2007-10-16

ApplicantSTERIS Corporation
Decision Date2007-10-16
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2007-10-16 under 510(k) number K071087. 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 VIS-U-ALL II HEAT-SEAL POUCH AND TUBING?

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING is a medical device that received FDA 510(k) clearance on 2007-10-16. The listed applicant is STERIS Corporation. The 510(k) number is K071087.

When did VIS-U-ALL II HEAT-SEAL POUCH AND TUBING receive FDA 510(k) clearance?

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING received FDA 510(k) clearance on 2007-10-16, under 510(k) number K071087.

Who is the listed applicant for VIS-U-ALL II HEAT-SEAL POUCH AND TUBING?

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

What is the FDA product code for VIS-U-ALL II HEAT-SEAL POUCH AND TUBING?

The FDA product code for VIS-U-ALL II HEAT-SEAL POUCH AND TUBING 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 STERIS Corporation 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.

K261055AMSCO 700 Steam SterilizerK251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K260766Celerity 5 HP Biological Indicator (LCB052)K252680Celerity™ 20 HP Biological IndicatorK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118K243876VERIFY STEAM Integrating Indicator

View all 196 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.

↑