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510(k) K010098

MODIFICATION TO CAVERMAP SURGICAL AID by Uromed Corp. — Product Code FGM

K010098 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "MODIFICATION TO CAVERMAP SURGICAL AID". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code FGM (Probe And Director, Gastro-Urology), a Class I device regulated under 21 CFR 876.4730. Uromed Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
January 11, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe And Director, Gastro-Urology
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Uromed Corp.

  • K010213 — MODIFICATION TO CAVERMAP SURGICAL AID (April 20, 2001)
  • K000507 — CAVERMAP SURGICAL AID (April 21, 2000)
  • K993436 — CAVERMAP SURGICAL AID (February 11, 2000)
  • K982226 — UROMED BRACHYTHERAPHY IODINE-125 SOURCES (May 13, 1999)
  • K980717 — UROMED SLING KIT (May 22, 1998)
  • 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 FGM

  • K041732 — CAVERMAP SURGICAL AID (September 21, 2004)
  • K031527 — MODIFICATION TO CAVERMAP SURGICAL AID (June 5, 2003)
  • K993436 — CAVERMAP SURGICAL AID (February 11, 2000)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)

FDA data resources