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510(k) K780137

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

K780137 is an FDA 510(k) premarket notification submitted by Greenwald Surgical Co., Inc. for the device "CLAMP, INCONTINENCE, BAUMRUCKER". The FDA issued a decision of Substantially Equivalent on April 28, 1978. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Greenwald Surgical Co., Inc. has at least 3 other 510(k) clearances on record.

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.

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

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)
  • 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)

FDA data resources