Home / 510(k) Clearances / K790253

510(k) K790253

URINARY DRAINAGE BAG by Snyder Laboratories, Inc. — Product Code KNX

K790253 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on April 10, 1979. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
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)
  • K800578 — SURGIVAC TM (April 16, 1980)
  • K800577 — SNYDER HEMOVAC TM VENTED WOUND KIT (April 16, 1980)
  • K800543 — SNYDER HYSTERECTOMY Y TUBE KIT (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)
  • K790419 — YANKAUER & POODLE SUCTION INSTRUMENTS (April 23, 1979)

Other clearances for product code KNX

  • K110518 — IBAG (June 24, 2011)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)
  • K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (December 11, 1997)
  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)

FDA data resources