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510(k) K952780

URINARY GEL DRAINAGE SYSTEM by P.A.M., Inc. — Product Code EYZ

K952780 is an FDA 510(k) premarket notification submitted by P.A.M., Inc. for the device "URINARY GEL DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 1995. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1995
Date Received
June 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances for product code EYZ

  • K964219 — ZIP CONDOM CATHETER (August 11, 1997)
  • K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10 (November 19, 1996)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAG (May 14, 1993)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)

FDA data resources