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FDA 510(k)

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR

K-Number: K010711 · 2001-05-22

ApplicantAdvanced Surgical Concepts (Asc)
Decision Date2001-05-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts (Asc). It received FDA 510(k) clearance on 2001-05-22 under 510(k) number K010711. 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 ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR?

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR is a medical device that received FDA 510(k) clearance on 2001-05-22. The listed applicant is Advanced Surgical Concepts (Asc). The 510(k) number is K010711.

When did ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR receive FDA 510(k) clearance?

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR received FDA 510(k) clearance on 2001-05-22, under 510(k) number K010711.

Who is the listed applicant for ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR?

The FDA 510(k) record lists Advanced Surgical Concepts (Asc) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR?

The FDA product code for ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR 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 Advanced Surgical Concepts (Asc) 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.

K011183OMNIPORT HAND AND INSTRUMENT ACCESS DEVICEK002013OMNIPORTK993544SPACE-OR RETRACTOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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