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FDA 510(k)

DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)

K-Number: K852280 · 1985-07-09

ApplicantOutpatient Products Co.
Decision Date1985-07-09
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) is the device name listed in this FDA 510(k) record. The listed applicant is Outpatient Products Co.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852280. 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 DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)?

DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Outpatient Products Co.. The 510(k) number is K852280.

When did DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) receive FDA 510(k) clearance?

DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852280.

Who is the listed applicant for DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)?

The FDA 510(k) record lists Outpatient Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)?

The FDA product code for DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) 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

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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