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510(k) K780137

CLAMP, INCONTINENCE, BAUMRUCKER by Greenwald Surgical Co., Inc. — Product Code FHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1978
Date Received
January 25, 1978
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 Greenwald Surgical Co., Inc.

  • K933174 — GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE (April 1, 1994)
  • K933173 — GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE (April 1, 1994)
  • K933175 — GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE (April 1, 1994)

Other clearances for product code FHA

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  • 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)
  • 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)