CUSHING BAYONET, INSULATED BIPOLAR FORCEP— 510(k) K974595

Name: FDA 510(k) clearance K974595
Creator: U.S. Food and Drug Administration
Published: 1998-06-24

Substantially Equivalent

Titan Mfg., Inc.

FDA 510(k) clearance K974595 for CUSHING BAYONET, INSULATED BIPOLAR FORCEP, Substantially Equivalent on 1998-06-24. Applicant: Titan Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Titan Mfg., Inc.
Product code: Code HTD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1997-12-09
Decision date: 1998-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenixville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTD

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K051281 — THE NEEDLE CATCHER2005-09-08
K974593 — SEMKIN INSULATED BIPOLAR FORCEP1998-06-24
K974594 — SEMKIN BIPOLAR FORCEP1998-06-24
K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS1991-10-23
K911180 — CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS1991-03-29

Adverse events under product code HTD

product code HTD

Malfunction: 892
Total: 892

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.