Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BOUFFANT-STYLE SURGICAL CAP

K-Number: K863359 · 1986-09-29

ApplicantKimberly-Clark Corp.
Decision Date1986-09-29
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUFFANT-STYLE SURGICAL CAP is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863359. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUFFANT-STYLE SURGICAL CAP?

BOUFFANT-STYLE SURGICAL CAP is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K863359.

When did BOUFFANT-STYLE SURGICAL CAP receive FDA 510(k) clearance?

BOUFFANT-STYLE SURGICAL CAP received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863359.

Who is the listed applicant for BOUFFANT-STYLE SURGICAL CAP?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUFFANT-STYLE SURGICAL CAP?

The FDA product code for BOUFFANT-STYLE SURGICAL CAP is FYF.

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

Other records listing Kimberly-Clark Corp. 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.

K131879KC 300 SURGICAL MASKK131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVEK131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEK120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGK112805KIMGUARD ONE-STEP STERILIZATION WRAPK113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

View all 102 devices →

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.

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.

↑