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510(k) K050256

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR by Apple Medical Corp. — Product Code GAD

K050256 is an FDA 510(k) premarket notification submitted by Apple Medical Corp. for the device "APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR". The FDA issued a decision of Substantially Equivalent on April 26, 2005. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Apple Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2005
Date Received
February 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • 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)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 1994)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (April 13, 2016)
  • K151104 — OTELO LL (January 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (October 4, 2013)
  • K071775 — DASH (August 7, 2007)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)
  • K942002 — RETRACTOR (May 17, 1994)

FDA data resources