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510(k) K051860

FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 by Epimed International, Inc. — Product Code MIA

K051860 is an FDA 510(k) premarket notification submitted by Epimed International, Inc. for the device "FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837". The FDA issued a decision of Substantially Equivalent on August 22, 2005. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Epimed International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Epimed International, Inc.

  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K200624 — Percutaneous Introducer (April 27, 2020)
  • K190256 — Rulo Radiofrequency Lesion Probe (March 8, 2019)
  • K133316 — SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED (May 28, 2014)
  • K072005 — RK EPIDURAL NEEDLE (February 7, 2008)
  • K053318 — RX EPIDURAL NEEDLE (February 17, 2006)
  • K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR (August 26, 2005)
  • K043467 — FLEXIBLE SPINAL NEEDLE (March 31, 2005)
  • K041021 — RF INTRODUCTION CANNULA (September 16, 2004)
  • K041843 — PENCIL POINT NEEDLE (August 24, 2004)

Other clearances for product code MIA

  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (January 29, 1999)
  • K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND (July 23, 1998)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED (July 2, 1996)
  • K960405 — SPINAL NEEDLE (February 28, 1996)
  • K942442 — ACUFEX T-FIX DELIVERY SYSTEM (December 5, 1994)
  • K904380 — SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (April 8, 1993)

FDA data resources