MICROTEK EQUIPMENT DRAPES— 510(k) K050322

Name: FDA 510(k) clearance K050322
Creator: U.S. Food and Drug Administration
Published: 2005-05-17

Substantially Equivalent

Microtek Medical, Inc.

FDA 510(k) clearance K050322 for MICROTEK EQUIPMENT DRAPES, Substantially Equivalent on 2005-05-17. Applicant: Microtek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Microtek Medical, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2005-02-09
Decision date: 2005-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, MS, US

Download summary PDF View on FDA.gov ↗

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K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Microtek Medical, Inc.

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K110358 — VENODYNE V8102011-05-05
K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK2011-02-23
K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA2007-01-25
K060200 — MICROTEK MEDICAL WARMING DRAPE2006-05-31
K022903 — CHILLBUSTER2002-11-27

Recalls naming K050322

K-number listed on FDA's recall record

Z-1380-2015 — da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1381-2015 — da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1382-2015 — da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1383-2015 — da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1384-2015 — da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1385-2015 — da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1386-2015 — da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1387-2015 — da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1388-2015 — da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1389-2015 — da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1390-2015 — da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1391-2015 — da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1392-2015 — da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1393-2015 — da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.Class II·Terminated·Intuitive Surgical, Inc.·20150316
Z-1995-2013 — Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.Class II·Terminated·Blue Belt Technologies MN·20130719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050322.

Data sourced from openFDA. This site is unofficial and independent of the FDA.