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510(k) K971992

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) by Uromed Corp. — Product Code FHA

K971992 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Uromed Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
May 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Penile
Device Class
Class I
Regulation Number
876.5160
Review Panel
GU
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)
  • 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)

Other clearances for product code FHA

  • K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE (July 14, 1998)
  • K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (April 2, 1997)
  • K964580 — CAP-AID (IMPROVED) (January 10, 1997)
  • K955810 — U-TEX (January 24, 1996)
  • K954959 — CAP-AID (December 6, 1995)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K896160 — WILLIAMS PENILE ANESTHETIC RETAINER (February 16, 1990)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K863227 — COOK-VPI CONTINENCE CUFF (February 3, 1987)
  • K780137 — CLAMP, INCONTINENCE, BAUMRUCKER (April 28, 1978)

FDA data resources