MICROTEK PROBE DRAPE— 510(k) K882724

Clearance details

Applicant

Microbio-Medics, Inc.

Product code

Code KKX

Device class

Class 2

Regulation

21 CFR 878.4370

Advisory panel

General, Plastic Surgery

Date received

1988-07-01

Decision date

1988-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Columbus, MS, US

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• Z-0753-2017 — Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.Class III·Terminated·Ecolab Inc·20161130
• Z-0974-2014 — 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe coverClass II·Terminated·Custom Medical Specialties, Inc.·20130712
• Z-0943-2014 — MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.Class II·Terminated·Ecolab Inc·20130702
• Z-0944-2014 — MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702Class II·Terminated·Ecolab Inc·20130702
• Z-0945-2014 — MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702Class II·Terminated·Ecolab Inc·20130702
• Z-0946-2014 — MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702Class II·Terminated·Ecolab Inc·20130702
• Z-0947-2014 — MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702Class II·Terminated·Ecolab Inc·20130702
• Z-0948-2014 — Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, IllinoisClass II·Terminated·Ecolab Inc·20130702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882724.