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)

BOUNDARY FABRIC III SURGICAL DRAPE

K-Number: K760932 · 1976-11-11

ApplicantProcter & Gamble Mfg. Co.
Decision Date1976-11-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY FABRIC III SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Procter & Gamble Mfg. Co.. It received FDA 510(k) clearance on 1976-11-11 under 510(k) number K760932. 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 BOUNDARY FABRIC III SURGICAL DRAPE?

BOUNDARY FABRIC III SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1976-11-11. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K760932.

When did BOUNDARY FABRIC III SURGICAL DRAPE receive FDA 510(k) clearance?

BOUNDARY FABRIC III SURGICAL DRAPE received FDA 510(k) clearance on 1976-11-11, under 510(k) number K760932.

Who is the listed applicant for BOUNDARY FABRIC III SURGICAL DRAPE?

The FDA 510(k) record lists Procter & Gamble Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUNDARY FABRIC III SURGICAL DRAPE?

The FDA product code for BOUNDARY FABRIC III SURGICAL DRAPE 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

Other records listing Procter & Gamble Mfg. Co. 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.

K873036ATTENDS INCONTINENT BRIEFK873457SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSK864673UNSCENTED MENSTRUAL PADK861863MODIFIED PROTECTIVE GARMENTK862348SINGLE-USE PATIENT UNDERPADK860598MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS

View all 72 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.

↑