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510(k) K812389

SURGICAL LOOPS by Berkeley Medevices — Product Code GAD

K812389 is an FDA 510(k) premarket notification submitted by Berkeley Medevices for the device "SURGICAL LOOPS". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Berkeley Medevices has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
August 20, 1981
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 Berkeley Medevices

  • K892220 — LAMINARIA TENT (June 14, 1989)
  • K840952 — MEDEVICE V-80 VACUUM PUMP (March 30, 1984)
  • K823006 — MEDEVICES ASPIRATION HOSE (November 4, 1982)
  • K812388 — SURGICAL PAWS (November 16, 1981)

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