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510(k) K790254

FOLEY CATHETERIZATION TRAY by Snyder Laboratories, Inc. — Product Code FCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1979
Date Received
February 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Snyder Laboratories, Inc.

  • K843906 — SNYDER HEMOVAC WOUND DRAINAGE DEVICES (November 5, 1984)
  • K821321 — SNYDER DEBRIBEMENT SYSTEM LDP-1 (August 6, 1982)
  • K800861 — SNYDER HEMOVAC CHEST DRAINAGE SOLUTION (May 2, 1980)
  • K800577 — SNYDER HEMOVAC TM VENTED WOUND KIT (April 16, 1980)
  • K800543 — SNYDER HYSTERECTOMY Y TUBE KIT (April 16, 1980)
  • K800578 — SURGIVAC TM (April 16, 1980)
  • K800542 — 100 ML SNYDER HEMOVAC (April 2, 1980)
  • K790607 — GREENLINE IRRIGATION TRAYS (May 11, 1979)
  • K790420 — SUCTION CONNECTING TUBING (April 23, 1979)
  • K790606 — CATHETERS, GREENLINE SUCTION (April 23, 1979)

Other clearances for product code FCM

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  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)