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FDA 510(k)

GENERAL SURGERY DRAPES

K-Number: K070432 · 2007-09-24

ApplicantWelmed, Inc.
Decision Date2007-09-24
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENERAL SURGERY DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Welmed, Inc.. It received FDA 510(k) clearance on 2007-09-24 under 510(k) number K070432. 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 GENERAL SURGERY DRAPES?

GENERAL SURGERY DRAPES is a medical device that received FDA 510(k) clearance on 2007-09-24. The listed applicant is Welmed, Inc.. The 510(k) number is K070432.

When did GENERAL SURGERY DRAPES receive FDA 510(k) clearance?

GENERAL SURGERY DRAPES received FDA 510(k) clearance on 2007-09-24, under 510(k) number K070432.

Who is the listed applicant for GENERAL SURGERY DRAPES?

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

What is the FDA product code for GENERAL SURGERY DRAPES?

The FDA product code for GENERAL SURGERY DRAPES 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.

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Other records listing Welmed, 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.

K070936WELMED HYPODERMIC SYRINGEK070431WELMED, INC. SURGICAL GOWNS

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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