Home / 510(k) Clearances / K853114

510(k) K853114

ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR by Australian Biomedical Corporation , Ltd. — Product Code GAD

K853114 is an FDA 510(k) premarket notification submitted by Australian Biomedical Corporation , Ltd. for the device "ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR". The FDA issued a decision of Substantially Equivalent on August 6, 1985. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Australian Biomedical Corporation , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1985
Date Received
July 24, 1985
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 Australian Biomedical Corporation , Ltd.

  • K871735 — VOROSCOPE(TM) (June 3, 1987)
  • K862457 — LYNX EL MICROSCOPY TISSUE PROCESSOR (July 16, 1986)
  • K851660 — DONWAY LIFTING FRAME (August 7, 1985)
  • K843522 — DONWAY SPLINT (February 7, 1985)

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)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • 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)

FDA data resources