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510(k) K821289

MAYO-HEGAR NEEDLE HOLDER by Conphar, Inc. — Product Code GDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1982
Date Received
May 4, 1982
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 Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (August 10, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (June 3, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821293 — BACKHAUS CLAMP, 5 1/4 (May 28, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821275 — MAYO SCISSOR STRAIGHT 5 1/2 (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)

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)