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510(k) K833541

SURGICAL INSTRUMENT by Hirata Sangyo Co. USA, Inc. — Product Code GAD

K833541 is an FDA 510(k) premarket notification submitted by Hirata Sangyo Co. USA, Inc. for the device "SURGICAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Hirata Sangyo Co. USA, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
September 27, 1983
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 Hirata Sangyo Co. USA, Inc.

  • K864106 — SR-MODEL 230 (MODIFICATION) (November 19, 1986)
  • K842289 — SR- MODEL 230 (July 25, 1984)
  • K833542 — SURGICAL INSTRUMENT (November 28, 1983)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K831583 — GP-303 (July 19, 1983)
  • K821989 — NON-STETHO 7, UM-15TP (October 18, 1982)
  • K822571 — SYRINGE PUMP (October 8, 1982)

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