FINE SURGICAL CIRCUMCISION CLAMP— 510(k) K040052

Name: FDA 510(k) clearance K040052
Creator: U.S. Food and Drug Administration
Published: 2004-04-09

Substantially Equivalent

Fine Surgical Instrument Corp.

FDA 510(k) clearance K040052 for FINE SURGICAL CIRCUMCISION CLAMP, Substantially Equivalent on 2004-04-09. Applicant: Fine Surgical Instrument Corp.. Device class: 2.

Clearance details

Applicant: Fine Surgical Instrument Corp.
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2004-01-12
Decision date: 2004-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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K151095 — Circumplast Circumcision Device2015-09-18
K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP2015-04-20

Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

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.