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510(k) K790306

EDGE PROTECTOR, BARRIER by Surgikos, Inc. — Product Code KGW

K790306 is an FDA 510(k) premarket notification submitted by Surgikos, Inc. for the device "EDGE PROTECTOR, BARRIER". The FDA issued a decision of Substantially Equivalent on February 22, 1979. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Surgikos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1979
Date Received
February 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring (Wound Protector), Drape Retention, Internal
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

Other clearances by Surgikos, Inc.

  • K875107 — HEALTH CARE EYE PROTECTION (March 21, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K861441 — NEUTRALON SURGICAL GLOVES (May 30, 1986)
  • K852870 — BARRIER SURGICAL GOWN (July 23, 1985)
  • K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION (September 30, 1982)
  • K820543 — BARRIER ANTIMICROBIAL INCISE DRAPE (July 22, 1982)
  • K820542 — SURGIKOS INCISE DRAPE (June 2, 1982)
  • K811871 — BACTERICIDAL INCISE DRAPE (August 20, 1981)
  • K810316 — SURGIKOS FACE MASK (February 23, 1981)
  • K801864 — BARRIER APERTURED DRAPE (August 20, 1980)

Other clearances for product code KGW

  • K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis l (April 24, 2026)
  • K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighte (February 23, 2026)
  • K113268 — ALEXIS O WOUND PROTECTOR/RETRACTOR (February 8, 2013)
  • K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR (April 2, 2010)
  • K093296 — ALEXIS LAPAROSCOPIC SYSTEM (November 5, 2009)
  • K062907 — ALEXIS WOUND RETRACTOR (January 9, 2007)
  • K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (August 26, 2004)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)

FDA data resources