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)

BARRIER SAF-TE HYDROGEL DRAPE

K-Number: K922918 · 1993-07-06

ApplicantJohnson & Johnson International
Decision Date1993-07-06
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER SAF-TE HYDROGEL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson International. It received FDA 510(k) clearance on 1993-07-06 under 510(k) number K922918. 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 SAF-TE HYDROGEL DRAPE?

BARRIER SAF-TE HYDROGEL DRAPE is a medical device that received FDA 510(k) clearance on 1993-07-06. The listed applicant is Johnson & Johnson International. The 510(k) number is K922918.

When did BARRIER SAF-TE HYDROGEL DRAPE receive FDA 510(k) clearance?

BARRIER SAF-TE HYDROGEL DRAPE received FDA 510(k) clearance on 1993-07-06, under 510(k) number K922918.

Who is the listed applicant for BARRIER SAF-TE HYDROGEL DRAPE?

The FDA 510(k) record lists Johnson & Johnson International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARRIER SAF-TE HYDROGEL DRAPE?

The FDA product code for BARRIER SAF-TE HYDROGEL 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_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 Johnson & Johnson International 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.

K965198ULTIMA TPS CEMENTED STEMK944937SYNTHETIC ABSORBABLE SUTUREK946245TIELLE* HYDROPOLYMER DRESSINGK942383DERMIVIEW CLEAR TAPEK923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUSK896828BIOCLUSIVE(R) ABSORBENT DRESSING

View all 10 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.

↑