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510(k) K925022

SURGICAL TRAY (STERILE) by Customed, Inc. — Product Code LRD

K925022 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "SURGICAL TRAY (STERILE)". The FDA issued a decision of Substantially Equivalent on April 26, 1993. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220. Customed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1993
Date Received
September 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent Drug
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Customed, Inc.

  • K260116 — CustoMED Viewer (June 3, 2026)
  • K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 (January 5, 1998)
  • K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (December 4, 1997)
  • K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277 (November 25, 1996)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K961442 — UNIVERSAL DRAINAGE TRAY (May 9, 1996)
  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)

Other clearances for product code LRD

  • K984345 — AROMAPATCH (March 19, 1999)
  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K942789 — MISTASSIST (August 12, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)

FDA data resources