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510(k) K954959

CAP-AID by Nebl, Inc. — Product Code FHA

K954959 is an FDA 510(k) premarket notification submitted by Nebl, Inc. for the device "CAP-AID". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Nebl, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
October 27, 1995
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 Nebl, Inc.

  • K983164 — RESTORE (AKA RE/STOR) (March 5, 1999)
  • K971359 — RESTORE (A.K.A. CAPSURE) (November 14, 1997)

Other clearances for product code FHA

  • K974040 — C3 EXTERNAL MALE BLADDER CONTROL DEVICE (July 14, 1998)
  • K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (August 1, 1997)
  • 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)
  • 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