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FDA 510(k)

SRI LP DRAPE

K-Number: K080796 · 2008-11-17

ApplicantSri/Surgical Express
Decision Date2008-11-17
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SRI LP DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Sri/Surgical Express. It received FDA 510(k) clearance on 2008-11-17 under 510(k) number K080796. 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 SRI LP DRAPE?

SRI LP DRAPE is a medical device that received FDA 510(k) clearance on 2008-11-17. The listed applicant is Sri/Surgical Express. The 510(k) number is K080796.

When did SRI LP DRAPE receive FDA 510(k) clearance?

SRI LP DRAPE received FDA 510(k) clearance on 2008-11-17, under 510(k) number K080796.

Who is the listed applicant for SRI LP DRAPE?

The FDA 510(k) record lists Sri/Surgical Express as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRI LP DRAPE?

The FDA product code for SRI LP 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 Sri/Surgical Express 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.

K080707SRI PLR GOWN

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.

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