Home / 510(k) Clearances / K041080

510(k) K041080

SURGICAL DRAPE KIT - D.I.R.R.A. SRL by D.I.R.R.A. S.R.L. — Product Code LRO

K041080 is an FDA 510(k) premarket notification submitted by D.I.R.R.A. S.R.L. for the device "SURGICAL DRAPE KIT - D.I.R.R.A. SRL". The FDA issued a decision of Substantially Equivalent on November 30, 2004. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2004
Date Received
April 26, 2004
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 for product code LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • 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)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)

FDA data resources