FDA 510(k)

BIOSHIELD EXPRESS STERILIZATION WRAP

K-Number: K983719 · 1999-08-25

Decision Date1999-08-25

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BIOSHIELD EXPRESS STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 1999-08-25 under 510(k) number K983719. 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 BIOSHIELD EXPRESS STERILIZATION WRAP?

BIOSHIELD EXPRESS STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1999-08-25. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K983719.

When did BIOSHIELD EXPRESS STERILIZATION WRAP receive FDA 510(k) clearance?

BIOSHIELD EXPRESS STERILIZATION WRAP received FDA 510(k) clearance on 1999-08-25, under 510(k) number K983719.

Who is the listed applicant for BIOSHIELD EXPRESS STERILIZATION WRAP?

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

What is the FDA product code for BIOSHIELD EXPRESS STERILIZATION WRAP?

The FDA product code for BIOSHIELD EXPRESS STERILIZATION WRAP 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Allegiance Healthcare Corp. as applicant

K023673AIRLIFE DEMAND NASAL CANNULA K023419TRILAMINATE DRAPES/TIBURON K024120MODIFICATION TO TEMNO BIOPSY NEEDLES K024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM K024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM K023425DRAPES WITH ABSORBENT REINFORCEMENT

View all 63 devices →

Related Devices (Code: FRG)

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, LLC K253454HALYARD* 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.