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)

QUALI-MED'S OPERATING ROOM DRAPES

K-Number: K862172 · 1986-06-19

ApplicantQuali-Med, Inc.
Decision Date1986-06-19
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALI-MED'S OPERATING ROOM DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Quali-Med, Inc.. It received FDA 510(k) clearance on 1986-06-19 under 510(k) number K862172. 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 QUALI-MED'S OPERATING ROOM DRAPES?

QUALI-MED'S OPERATING ROOM DRAPES is a medical device that received FDA 510(k) clearance on 1986-06-19. The listed applicant is Quali-Med, Inc.. The 510(k) number is K862172.

When did QUALI-MED'S OPERATING ROOM DRAPES receive FDA 510(k) clearance?

QUALI-MED'S OPERATING ROOM DRAPES received FDA 510(k) clearance on 1986-06-19, under 510(k) number K862172.

Who is the listed applicant for QUALI-MED'S OPERATING ROOM DRAPES?

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

What is the FDA product code for QUALI-MED'S OPERATING ROOM DRAPES?

The FDA product code for QUALI-MED'S OPERATING ROOM DRAPES 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 Quali-Med, 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.

K871408BLOOD VESSEL CONNECTORK862972DISPOSABLE MIRRORK862472QUARTZ RODS TITANIUM RODSK862241STANDARD BASIN KIT CUSTOM BASIN KITK862242PAP SMEAR KITK861198CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)

View all 7 devices →

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.

↑