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510(k) K963265

PROSYS SAMEC LA by Convatec, A Division of E.R. Squibb & Sons — Product Code EXJ

K963265 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "PROSYS SAMEC LA". The FDA issued a decision of Substantially Equivalent on October 25, 1996. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250. Convatec, A Division of E.R. Squibb & Sons has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1996
Date Received
August 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Convatec, A Division of E.R. Squibb & Sons

  • K090254 — SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (September 4, 2009)
  • K080383 — AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (May 2, 2008)
  • K063271 — AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED AN (April 16, 2007)
  • K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING (June 21, 2002)
  • K990964 — SIGNADRESS DUODERM DRESSING (May 18, 1999)
  • K984388 — HA ABSORBENT WOUND DRESSING (March 3, 1999)
  • K980720 — NONWOVEN PAD (April 15, 1998)
  • K980382 — NON-WOVEN COMPRESS (March 9, 1998)
  • K974823 — NONWOVEN DRESSING (February 20, 1998)
  • K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)

Other clearances for product code EXJ

  • K970465 — BOUSER'S URINAL (December 18, 1997)
  • K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (July 31, 1997)
  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER (September 16, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K945628 — CLEAR ADVANTAGE II (July 6, 1995)
  • K951530 — PROSYS URIHESIVE SYSTEM LA (May 12, 1995)
  • K950690 — PROSYS URIHESICE SYSTEM NL (March 23, 1995)

FDA data resources