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)

ALL-HANDS STERILE FIELD-0201

K-Number: K842545 · 1984-08-01

ApplicantAll-Hands Medical Supply, Inc.
Decision Date1984-08-01
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALL-HANDS STERILE FIELD-0201 is the device name listed in this FDA 510(k) record. The listed applicant is All-Hands Medical Supply, Inc.. It received FDA 510(k) clearance on 1984-08-01 under 510(k) number K842545. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL-HANDS STERILE FIELD-0201?

ALL-HANDS STERILE FIELD-0201 is a medical device that received FDA 510(k) clearance on 1984-08-01. The listed applicant is All-Hands Medical Supply, Inc.. The 510(k) number is K842545.

When did ALL-HANDS STERILE FIELD-0201 receive FDA 510(k) clearance?

ALL-HANDS STERILE FIELD-0201 received FDA 510(k) clearance on 1984-08-01, under 510(k) number K842545.

Who is the listed applicant for ALL-HANDS STERILE FIELD-0201?

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

What is the FDA product code for ALL-HANDS STERILE FIELD-0201?

The FDA product code for ALL-HANDS STERILE FIELD-0201 is KKX.

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 All-Hands Medical Supply, Inc. 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.

K842953ALL-HANDS MEDICAL SUPPLY SUTURE REMOVALK842415ALL-HANDS TRACHEOSTOMY CARE SET 0101

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.

↑