FDA 510(k)

ABDOMINAL / THORACIC PATIENT DRAPE

K-Number: K930815 · 1994-05-05

Decision Date1994-05-05

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ABDOMINAL / THORACIC PATIENT DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1994-05-05 under 510(k) number K930815. 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 ABDOMINAL / THORACIC PATIENT DRAPE?

ABDOMINAL / THORACIC PATIENT DRAPE is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Custom Medical Products, Ltd.. The 510(k) number is K930815.

When did ABDOMINAL / THORACIC PATIENT DRAPE receive FDA 510(k) clearance?

ABDOMINAL / THORACIC PATIENT DRAPE received FDA 510(k) clearance on 1994-05-05, under 510(k) number K930815.

Who is the listed applicant for ABDOMINAL / THORACIC PATIENT DRAPE?

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

What is the FDA product code for ABDOMINAL / THORACIC PATIENT DRAPE?

The FDA product code for ABDOMINAL / THORACIC PATIENT 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Custom Medical Products, Ltd. as applicant

K931417STERILE EQUIPMENT COVERS K931456SURGICAL DRAPE AND GOWN TRAY K931455HEAD SHEET K931418SURGICAL DRAPE K931844CUSTOM PROCEDURE MEDICAL TRAY OR KIT K926519SURGICAL GOWN

View all 13 devices →

Related Devices (Code: KKX)

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad 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.