FDA 510(k)

BARRIER TOWEL DRAPE

K-Number: K801863 · 1980-08-20

Decision Date1980-08-20

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BARRIER TOWEL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801863. 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 BARRIER TOWEL DRAPE?

BARRIER TOWEL DRAPE is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Surgikos, Inc.. The 510(k) number is K801863.

When did BARRIER TOWEL DRAPE receive FDA 510(k) clearance?

BARRIER TOWEL DRAPE received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801863.

Who is the listed applicant for BARRIER TOWEL DRAPE?

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

What is the FDA product code for BARRIER TOWEL DRAPE?

The FDA product code for BARRIER TOWEL DRAPE 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_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 Surgikos, Inc. as applicant

K875107HEALTH CARE EYE PROTECTION K874653STERILE SURGICAL SCRUB BRUSH K861441NEUTRALON SURGICAL GLOVES K852870BARRIER SURGICAL GOWN K822535CIDEX*DIALYZER DISINFECTING SOLUTION K820543BARRIER ANTIMICROBIAL INCISE DRAPE

View all 56 devices →

Related Devices (Code: KKX)

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad 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.