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510(k) K771859

NEEDLE HOLDER, MICROVASCULAR by Edward Weck, Inc. — Product Code FHQ

K771859 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "NEEDLE HOLDER, MICROVASCULAR". The FDA issued a decision of Substantially Equivalent on October 4, 1977. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1977
Date Received
September 29, 1977
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 Edward Weck, Inc.

  • K915378 — WECK TROCAR (June 29, 1992)
  • K914690 — LM15(TM), CATALOG NUMBER - 523821 (March 23, 1992)
  • K911915 — HEMOCLIP II (January 9, 1992)
  • K914470 — PNEUMO-SEAL(TM) (November 29, 1991)
  • K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (July 2, 1991)
  • K902108 — HEM-O-LOK(TM) (August 6, 1990)
  • K902232 — WECK ELECTROSURGICAL GENERATOR #174200 (August 2, 1990)
  • K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018 (February 15, 1990)
  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
  • K851251 — AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 (July 2, 1985)

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)
  • K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLES (May 26, 1993)
  • K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS (June 20, 1985)
  • K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS (June 20, 1985)

FDA data resources