NEEDLE HOLDER, MICROVASCULAR— 510(k) K771859

Name: FDA 510(k) clearance K771859
Creator: U.S. Food and Drug Administration
Published: 1977-10-04

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K771859 for NEEDLE HOLDER, MICROVASCULAR, Substantially Equivalent on 1977-10-04. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code FHQ
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1977-09-29
Decision date: 1977-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHQ

view all

K974327 — WINGED NEEDLE HOLDER1998-01-09
K924196 — LAPAROSCOPIC NEEDLE HOLDER1993-06-25
K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATION1993-06-08
K920706 — MAGNETIC POINT GUARD FOR SURGICAL NEEDLES1993-05-26
K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS1985-06-20

More clearances from Edward Weck, Inc.

view all

K915378 — WECK TROCAR1992-06-29
K914690 — LM15(TM), CATALOG NUMBER - 5238211992-03-23
K911915 — HEMOCLIP II1992-01-09
K914470 — PNEUMO-SEAL(TM)1991-11-29
K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 1147051991-07-02

Adverse events under product code FHQ

product code FHQ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.