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510(k) K952841

THE ASSISTANT by Apple Medical Corp. — Product Code FHA

K952841 is an FDA 510(k) premarket notification submitted by Apple Medical Corp. for the device "THE ASSISTANT". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code FHA (Clamp, Penile), a Class I device regulated under 21 CFR 876.5160. Apple Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1995
Date Received
June 21, 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 Apple Medical Corp.

  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K041131 — APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR (May 13, 2004)
  • K014005 — APPLE MEDICAL MOBIUS ELASTIC RETRACTOR (February 15, 2002)
  • K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (March 31, 2000)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K961460 — LWEET CONE BIOPSY INSTRUMENT (November 19, 1996)
  • K941506 — URETERAL ILLUMINATOR (October 5, 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)
  • 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