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510(k) K852330

RETRACTOR, SURGICAL by Scholten Surgical Instruments, Inc. — Product Code GAD

K852330 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "RETRACTOR, SURGICAL". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
May 31, 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 Scholten Surgical Instruments, Inc.

  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (August 1, 1986)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852329 — STAND, OPERATING ROOM (June 14, 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