510(k) K934688

STERILE DESIGN by Sterile Design, Inc. — Product Code LRO

Clearance Details

Decision: SEKD (Substantially Equivalent (kit, denovo))
Decision Date: March 16, 1994
Date Received: September 30, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: General Surgery Tray
Device Class: Class II
Regulation Number: 878.4370
Review Panel: SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other clearances by Sterile Design, Inc.

K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
K842356 — CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
K834239 — SDI C-FLEX STERILE LIGHT HANDLE (April 25, 1984)
K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
K813437 — PAN SET (December 31, 1981)
K791738 — CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)

Other clearances for product code LRO

K213481 — Medline General Surgery Tray (May 24, 2022)
K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)