Home / 510(k) Clearances / K971499

510(k) K971499

FEMALE EXTERNAL URINARY COLLECTION POUCH by Mediquest, Inc. — Product Code EXI

K971499 is an FDA 510(k) premarket notification submitted by Mediquest, Inc. for the device "FEMALE EXTERNAL URINARY COLLECTION POUCH". The FDA issued a decision of Substantially Equivalent on August 28, 1997. The device falls under product code EXI (Device, Paste-On For Incontinence, Sterile), a Class I device regulated under 21 CFR 876.5250. Mediquest, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1997
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Paste-On For Incontinence, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Mediquest, Inc.

  • K840089 — SKIN STAPLE REMOVER (March 5, 1984)

Other clearances for product code EXI

  • K970443 — HOLLISTER RETRACTED PENIS POUCH (February 25, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K931277 — HOLLISTER PREMIUM URINE COLLECTOR (June 23, 1993)
  • K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (June 22, 1993)
  • K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (February 5, 1992)
  • K915616 — URIHESIVE STRIP (January 23, 1992)

FDA data resources