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510(k) K880905

MAMMOGRAPHY MOVING GRID BUCKY by Custom Medical Products, Ltd. — Product Code IZH

K880905 is an FDA 510(k) premarket notification submitted by Custom Medical Products, Ltd. for the device "MAMMOGRAPHY MOVING GRID BUCKY". The FDA issued a decision of Substantially Equivalent on March 21, 1988. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Custom Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1988
Date Received
March 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Custom Medical Products, Ltd.

  • K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCED (June 9, 2000)
  • K931417 — STERILE EQUIPMENT COVERS (July 6, 1995)
  • K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
  • K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
  • K931418 — SURGICAL DRAPE (May 5, 1994)
  • K931455 — HEAD SHEET (May 5, 1994)
  • K931844 — CUSTOM PROCEDURE MEDICAL TRAY OR KIT (January 25, 1994)
  • K926519 — SURGICAL GOWN (August 12, 1993)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources