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FDA 510(k)

MODIFICATION TO: COMPEL SURGICAL DRAPES

K-Number: K012807 · 2001-10-11

ApplicantStandard Textile Co., Inc.
Decision Date2001-10-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: COMPEL SURGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2001-10-11 under 510(k) number K012807. 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 MODIFICATION TO: COMPEL SURGICAL DRAPES?

MODIFICATION TO: COMPEL SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 2001-10-11. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K012807.

When did MODIFICATION TO: COMPEL SURGICAL DRAPES receive FDA 510(k) clearance?

MODIFICATION TO: COMPEL SURGICAL DRAPES received FDA 510(k) clearance on 2001-10-11, under 510(k) number K012807.

Who is the listed applicant for MODIFICATION TO: COMPEL SURGICAL DRAPES?

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

What is the FDA product code for MODIFICATION TO: COMPEL SURGICAL DRAPES?

The FDA product code for MODIFICATION TO: COMPEL SURGICAL DRAPES is KKX.

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Other records listing Standard Textile Co., 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.

K241214ProPel SG3™ Surgical GownK172207Standard Supreme Sterilization WrapperK162162Barrier Supreme Sterilization WrapperK060181COMPE1 1 -PLY SURGICAL GOWNSK041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSK041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

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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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