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FDA 510(k)

SURGICAL DRAPES, MODIFICATION

K-Number: K931146 · 1994-06-13

ApplicantAmsco Sterile Recoveries, Inc.
Decision Date1994-06-13
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPES, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Sterile Recoveries, Inc.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K931146. 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 SURGICAL DRAPES, MODIFICATION?

SURGICAL DRAPES, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Amsco Sterile Recoveries, Inc.. The 510(k) number is K931146.

When did SURGICAL DRAPES, MODIFICATION receive FDA 510(k) clearance?

SURGICAL DRAPES, MODIFICATION received FDA 510(k) clearance on 1994-06-13, under 510(k) number K931146.

Who is the listed applicant for SURGICAL DRAPES, MODIFICATION?

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

What is the FDA product code for SURGICAL DRAPES, MODIFICATION?

The FDA product code for SURGICAL DRAPES, MODIFICATION is KKX.

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Other records listing Amsco Sterile Recoveries, 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.

K932522AMSCO STERILE RECOVERIES SURGICAL PACKSK931143AMSCO STERILE RECOVERIES ABSORBENT TOWELSK931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USEK931145NON-STERILE ISOLATION GOWNK931144STERILE SURGEON'S GOWN, MODIFICATIONK931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE

View all 12 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.

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