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510(k) K931727

URINARY DRAINAGE BAG CADDY by Neotech Products, Inc. — Product Code FAQ

K931727 is an FDA 510(k) premarket notification submitted by Neotech Products, Inc. for the device "URINARY DRAINAGE BAG CADDY". The FDA issued a decision of Substantially Equivalent on July 23, 1993. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Neotech Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1993
Date Received
March 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Neotech Products, Inc.

  • K011564 — NEOLEAD (January 3, 2002)
  • K921024 — URO-TOTE LEG BAG (September 2, 1992)
  • K890425 — NEOTECH MUCUS TRAP W/CATHETER (April 19, 1989)
  • K882203 — NEOTECH UNIVERSAL ADAPTER (June 17, 1988)
  • K880487 — NEOTECH MECONIUM ASPIRATOR (STERILE) (May 6, 1988)

Other clearances for product code FAQ

  • K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZ (July 18, 1996)
  • K960217 — CPR URINE BAG (March 28, 1996)
  • K955609 — CONVEEN URINE BAG - STERILE (December 29, 1995)
  • K953767 — PROSYS BEDSIDE DRAINAGE BAG (December 20, 1995)
  • K953783 — CONVEEN LEG BAG STRAP (September 13, 1995)
  • K951945 — PROSYS LEG BAG (May 25, 1995)
  • K945204 — URINE COLLECTOR & ACCESSORIES (November 2, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)
  • K924406 — CONVEEN(R) LEG BAG(500 ML) (October 30, 1992)

FDA data resources