Home / 510(k) Clearances / K830585

510(k) K830585

ANVIL RETRACTOR by Twin City Surgical, Inc. — Product Code GAD

K830585 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "ANVIL RETRACTOR". The FDA issued a decision of Substantially Equivalent on May 27, 1983. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
February 23, 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 Twin City Surgical, Inc.

  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K861632 — SIMS CHAIR (May 27, 1986)
  • K820659 — A CALIPER (March 19, 1982)
  • K820660 — A HOOK DRIVER (March 19, 1982)
  • K813067 — SPINAL WRENCH (November 24, 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