510(k) K945831

DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT by Micromed Development Corp. — Product Code LRO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 20, 1995
Date Received: November 29, 1994
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 Micromed Development Corp.

K945105 — POLY/PLATINUM WIRE PISTON (May 14, 1996)
K945242 — NERVE MONITOR ELECTRODES/STIMULATOR PROBES (December 27, 1994)
K945438 — EDI-BUR MICRODRILL SYSTEMS (November 22, 1994)
K945108 — POLY PISTON (November 22, 1994)
K945107 — POLY-WIRE PISTON (November 22, 1994)
K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
K945104 — MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)
K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

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)