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510(k) K930330

ENDOSCOPIC NEEDLEHOLDER, MODIFICATION by Holmed Corp. — Product Code FHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1993
Date Received
January 22, 1993
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 Holmed Corp.

  • K942597 — CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR (August 15, 1994)

Other clearances for product code FHQ

  • K974327 — WINGED NEEDLE HOLDER (January 9, 1998)
  • K924196 — LAPAROSCOPIC NEEDLE HOLDER (June 25, 1993)
  • K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLES (May 26, 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)