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510(k) K942807

SURGICAL LIFT SHEET by Surgin Surgical Instrumentation, Inc. — Product Code FSA

K942807 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "SURGICAL LIFT SHEET". The FDA issued a decision of Substantially Equivalent on August 2, 1994. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
June 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Non-Ac-Powered
Device Class
Class I
Regulation Number
880.5510
Review Panel
HO
Submission Type

Other clearances by Surgin Surgical Instrumentation, Inc.

  • K082110 — DUAL SYRINGE HOLDER (June 17, 2009)
  • K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2 (March 26, 2004)
  • K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (January 30, 2004)
  • K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511 (November 6, 2001)
  • K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (March 15, 2000)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K954238 — SURGIN GENISIS HANDPIECE (December 8, 1995)
  • K950600 — VACUUM SURGE SUPRESSER (May 10, 1995)
  • K942945 — CASSETTE SYSTEM FOR STORZ (December 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (September 27, 1994)

Other clearances for product code FSA

  • K930625 — SANITAS PATIENT LIFT (September 13, 1993)
  • K902141 — ANOLIFT - PORTABLE & ANOLIFT - GANTRY (September 12, 1990)
  • K860837 — HOYER ONE-TOUCH POWER LIFTER (March 27, 1986)
  • K851844 — MOLIFT (May 17, 1985)
  • K844976 — MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT (April 1, 1985)
  • K841395 — SHOWER TROLLEY (May 7, 1984)
  • K841398 — VARIABLE HEIGHT TRANSFER CHAIR (May 7, 1984)
  • K840997 — BATTERY POWERED PATIENT LIFT (April 17, 1984)
  • K823206 — MARTIN PELVIC LIFT (April 28, 1983)
  • K811899 — CENTURY LIFT TRANSFER SYSTEM (July 23, 1981)

FDA data resources