Home / 510(k) Clearances / K770590

510(k) K770590

SURGI-KIT by Ethox Corp. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1977
Date Received
March 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Ethox Corp.

  • K040286 — ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS (March 15, 2004)
  • K031195 — CUF-COVER (TM) (October 10, 2003)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K935633 — NO-MES (September 30, 1994)
  • K921946 — TUM-E-VAC BITE BLOCK (December 9, 1992)
  • K885220 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (September 25, 1989)
  • K894927 — SURGI SQUEEZ (September 11, 1989)
  • K883977 — SURGI-CUF STERILE/NON-STERILE DISPOSABLE (February 10, 1989)
  • K860599 — ETHOX LAVAGE TUBE (March 11, 1986)
  • K844988 — ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (April 4, 1985)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)