Home / 510(k) Clearances / K980717

510(k) K980717

UROMED SLING KIT by Uromed Corp. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1998
Date Received
February 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Uromed Corp.

  • K010213 — MODIFICATION TO CAVERMAP SURGICAL AID (April 20, 2001)
  • K010098 — MODIFICATION TO CAVERMAP SURGICAL AID (February 1, 2001)
  • K000507 — CAVERMAP SURGICAL AID (April 21, 2000)
  • K993436 — CAVERMAP SURGICAL AID (February 11, 2000)
  • K982226 — UROMED BRACHYTHERAPHY IODINE-125 SOURCES (May 13, 1999)
  • K974600 — UROMED PATCH (March 31, 1998)
  • K974137 — UROMED NEEDLE GRASPER (January 30, 1998)
  • K970971 — URO MED NERVE STIMULATOR (October 27, 1997)
  • K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (August 1, 1997)

Other clearances for product code KNA

  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 2014)
  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (April 14, 2010)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (October 27, 2006)
  • K060289 — EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (July 7, 2006)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K014248 — DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (March 21, 2002)
  • K001590 — DND 101 (August 2, 2000)
  • K990738 — DR. JAHANGER'S CUTTER (October 29, 1999)