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510(k) K920706

MAGNETIC POINT GUARD FOR SURGICAL NEEDLES by Retrax — Product Code FHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
February 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle, Gastroenterologic
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Retrax

  • K901508 — RETRAX SAFETY SYRINGE (June 14, 1990)

Other clearances for product code FHQ

  • K974327 — WINGED NEEDLE HOLDER (January 9, 1998)
  • K924196 — LAPAROSCOPIC NEEDLE HOLDER (June 25, 1993)
  • K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATION (June 8, 1993)
  • K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS (June 20, 1985)
  • K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS (June 20, 1985)
  • K771859 — NEEDLE HOLDER, MICROVASCULAR (October 4, 1977)