LAPAROSCOPIC NEEDLE HOLDER— 510(k) K924196

Name: FDA 510(k) clearance K924196
Creator: U.S. Food and Drug Administration
Published: 1993-06-25

Substantially Equivalent

Nusurg, Inc.

FDA 510(k) clearance K924196 for LAPAROSCOPIC NEEDLE HOLDER, Substantially Equivalent on 1993-06-25. Applicant: Nusurg, Inc.. Device class: 1.

Clearance details

Applicant: Nusurg, Inc.
Product code: Code FHQ
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1992-08-20
Decision date: 1993-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHQ

view all

K974327 — WINGED NEEDLE HOLDER1998-01-09
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
K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS1985-06-20

More clearances from Nusurg, Inc.

view all

K924792 — MULTIPLE PURPOSE FORCEPS1994-04-28
K930610 — TALC DISPENSER SYRINGE1993-11-04
K924517 — AVITENE DISPENSER SYRINGE1993-10-27
K924372 — LAPAROSCOPIC NERVE HOOK1993-07-30

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.