Atlas FDA

MICROTEK PROBE DRAPE

FDA 510(k) clearance K882724 · decided 1988-08-03

Clearance details

K-number
K882724
Device name
MICROTEK PROBE DRAPE
Applicant
Microbio-Medics, Inc.
Decision
Substantially Equivalent
Date received
1988-07-01
Decision date
1988-08-03
Days to decision
33 days
Clearance type
Traditional
Product code
KKX
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Columbus, MS, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645)Avery Dennison Medical , Ltd.2023-10-25
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578)3M Company2023-05-18
BeneHold Surgical Incise Drape with CHG antimicrobial (K202208)Avery Dennison Belgie Bvba2021-07-30
ControlRad Sterile Cover (K200238)Controlrad, Inc.2020-04-26
MediClear PreOp (K163556)Covalontechnologies, Inc.2017-09-14
Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
HONGYU DISPOSABLE SURGICAL DRAPES (K141324)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
SURGICAL DRAPE (K140195)Griffith-Lucas, LLC2014-09-10
3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330)3M Healthcare2014-08-18
WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438)Whitney Medical Solutions2014-08-14
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250)3M Healthcare2014-07-25
SURGISLEEVE WOUND PROTECTOR (K140064)Covidien2014-03-12

Recalls involving this device

RecordFirmDate
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, I recall (Z-0974-2014)Custom Medical Specialties, Inc.2014-02-12
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, recall (Z-0943-2014)Ecolab Inc2014-02-10
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm recall (Z-0944-2014)Ecolab Inc2014-02-10
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x recall (Z-0945-2014)Ecolab Inc2014-02-10
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (1 recall (Z-0946-2014)Ecolab Inc2014-02-10
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 recall (Z-0947-2014)Ecolab Inc2014-02-10
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STER recall (Z-0948-2014)Ecolab Inc2014-02-10