FDA 510(k)

WRAP, STERILIZATION

K-Number: K781301 · 1978-08-10

Decision Date1978-08-10

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

WRAP, STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Stanford Professional Products. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K781301. 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 WRAP, STERILIZATION?

WRAP, STERILIZATION is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Stanford Professional Products. The 510(k) number is K781301.

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

WRAP, STERILIZATION received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781301.

Who is the listed applicant for WRAP, STERILIZATION?

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

What is the FDA product code for WRAP, STERILIZATION?

The FDA product code for WRAP, STERILIZATION 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 Stanford Professional Products as applicant

K790050SPONGES, STANFORD STERILE LAP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.