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)

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE

K-Number: K922100 · 1993-03-15

ApplicantGraham Medical Products
Decision Date1993-03-15
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Graham Medical Products. It received FDA 510(k) clearance on 1993-03-15 under 510(k) number K922100. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is a medical device that received FDA 510(k) clearance on 1993-03-15. The listed applicant is Graham Medical Products. The 510(k) number is K922100.

When did DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE receive FDA 510(k) clearance?

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE received FDA 510(k) clearance on 1993-03-15, under 510(k) number K922100.

Who is the listed applicant for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

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

What is the FDA product code for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE?

The FDA product code for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE is EJJ.

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 Graham Medical Products 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.

K921657VASECTOMY DRAPEK922059DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913447DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913448DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEK913560STOPCOCKK903726DRAPE, SURGICAL - UTILITY DRAPE - STERILE

View all 9 devices →

Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

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.

↑