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510(k) K882075

SELF-RETAINING SOFT TISSUE RETRACTOR by Karlin Technology, Inc. — Product Code GAD

K882075 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "SELF-RETAINING SOFT TISSUE RETRACTOR". The FDA issued a decision of Substantially Equivalent on June 16, 1988. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1988
Date Received
May 17, 1988
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 Karlin Technology, Inc.

  • K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (September 5, 1990)
  • K893203 — BONE SCREW (April 4, 1990)
  • K893201 — BONE PLATE (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882519 — X-RAY MARKER (August 9, 1988)
  • K882073 — SPINAL NEEDLE (July 18, 1988)
  • K882520 — SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)

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