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)

ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE

K-Number: K960045 · 1996-06-05

ApplicantThe Sewing Source, Inc.
Decision Date1996-06-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is The Sewing Source, Inc.. It received FDA 510(k) clearance on 1996-06-05 under 510(k) number K960045. 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 ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE?

ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1996-06-05. The listed applicant is The Sewing Source, Inc.. The 510(k) number is K960045.

When did ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE receive FDA 510(k) clearance?

ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE received FDA 510(k) clearance on 1996-06-05, under 510(k) number K960045.

Who is the listed applicant for ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE?

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

What is the FDA product code for ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE?

The FDA product code for ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL 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 The Sewing Source, 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.

K921156O.R./SURGEONS GOWN, ITEM NO.4941K921158O.R./SURGEONS GOWN, ITEM NO. 4950K921157O.R./SURGEONS GOWN, ITEM NO. 4942K921154O.R./SURGEONS GOWN, ITEM NO. 4962K921155O.R./SURGEONS GOWN, ITEM NO. 4962K921152O.R./SURGEONS GOWN, ITEM NO. 4952

View all 9 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.

↑