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510(k) K904172

ACCUPLACE (TM) by Dlp, Inc. — Product Code GDF

K904172 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "ACCUPLACE (TM)". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Dlp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
September 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Dlp, Inc.

  • K973485 — CLEARVIEW BLOWER/MISTER (December 8, 1997)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTR (March 26, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K934215 — CONTAIN-OR (February 9, 1994)
  • K915268 — CATHETER TWO STAGE VENOUS RETURN (July 27, 1992)
  • K913077 — LANCASTER COOLING JACKET, CAT. CODE #13500/13501 (January 9, 1992)
  • K914608 — BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (January 9, 1992)
  • K913098 — APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 (November 5, 1991)
  • K912229 — IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 (September 25, 1991)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)

FDA data resources