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)

NORTEC STERILE WATER FOR DEVICE IRRIGATION

K-Number: K925593 · 1993-12-03

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1993-12-03
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NORTEC STERILE WATER FOR DEVICE IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1993-12-03 under 510(k) number K925593. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTEC STERILE WATER FOR DEVICE IRRIGATION?

NORTEC STERILE WATER FOR DEVICE IRRIGATION is a medical device that received FDA 510(k) clearance on 1993-12-03. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K925593.

When did NORTEC STERILE WATER FOR DEVICE IRRIGATION receive FDA 510(k) clearance?

NORTEC STERILE WATER FOR DEVICE IRRIGATION received FDA 510(k) clearance on 1993-12-03, under 510(k) number K925593.

Who is the listed applicant for NORTEC STERILE WATER FOR DEVICE IRRIGATION?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTEC STERILE WATER FOR DEVICE IRRIGATION?

The FDA product code for NORTEC STERILE WATER FOR DEVICE IRRIGATION is LDQ.

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 North American Sterilization & Packaging Co. 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.

K964231NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)K963753NASP TRANSPARENT DRESSINGK962352HYDROGEL SKIN DRESSINGK925588NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRIK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIOK911865NORTEC CONNECTING TUBE SET

View all 16 devices →

Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & 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.

↑