FDA 510(k)

STERITITE SEALED CONTAINERS MODEL SCO4Q

K-Number: K974638 · 1997-12-18

Decision Date1997-12-18

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERITITE SEALED CONTAINERS MODEL SCO4Q is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K974638. 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 STERITITE SEALED CONTAINERS MODEL SCO4Q?

STERITITE SEALED CONTAINERS MODEL SCO4Q is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Case Medical, Inc.. The 510(k) number is K974638.

When did STERITITE SEALED CONTAINERS MODEL SCO4Q receive FDA 510(k) clearance?

STERITITE SEALED CONTAINERS MODEL SCO4Q received FDA 510(k) clearance on 1997-12-18, under 510(k) number K974638.

Who is the listed applicant for STERITITE SEALED CONTAINERS MODEL SCO4Q?

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

What is the FDA product code for STERITITE SEALED CONTAINERS MODEL SCO4Q?

The FDA product code for STERITITE SEALED CONTAINERS MODEL SCO4Q 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 Case Medical, Inc. as applicant

K252854SteriTite Container System with MediTray Products K221492SteriTite Container System with MediTray Parts K212711SteriTite Container System with MediTray Products K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories K161415SteriTite Containers System & MediTray Products K112904STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS

View all 15 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.