MAGNETIC POINT GUARD FOR SURGICAL NEEDLES— 510(k) K920706

Name: FDA 510(k) clearance K920706
Creator: U.S. Food and Drug Administration
Published: 1993-05-26

Substantially Equivalent

Retrax

FDA 510(k) clearance K920706 for MAGNETIC POINT GUARD FOR SURGICAL NEEDLES, Substantially Equivalent on 1993-05-26. Applicant: Retrax. Device class: 1.

Clearance details

Applicant: Retrax
Product code: Code FHQ
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-18
Decision date: 1993-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wausau, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHQ

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K974327 — WINGED NEEDLE HOLDER1998-01-09
K924196 — LAPAROSCOPIC NEEDLE HOLDER1993-06-25
K930330 — ENDOSCOPIC NEEDLEHOLDER, MODIFICATION1993-06-08
K851779 — 25-100,25-220 VARIOUS NEEDLE HOLDERS1985-06-20
K851780 — 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS1985-06-20

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.