Cleared Traditional

K974595 - CUSHING BAYONET, INSULATED BIPOLAR FORCEP

K974595 is an FDA 510(k) clearance for CUSHING BAYONET, manufactured by Titan Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K974595 · Titan Mfg., Inc. · General & Plastic Surgery device
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Jun 1998
Decision
197d
Days
Class 1
Risk

K974595 is an FDA 510(k) clearance for the CUSHING BAYONET, INSULATED BIPOLAR FORCEP. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Titan Mfg., Inc. (Phoenixville, US). The FDA issued a Cleared decision on June 24, 1998 after a review of 197 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Titan Mfg., Inc. devices

FDA 510(k) Submission Details - K974595

510(k) Number K974595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date June 24, 1998
Days to Decision 197 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

Product Code HTD Forceps
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HTD Forceps

All 61
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K974595.
SEMKIN INSULATED BIPOLAR FORCEP
K974593 · Titan Mfg., Inc. · Jun 1998
SEMKIN BIPOLAR FORCEP
K974594 · Titan Mfg., Inc. · Jun 1998
MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS
K913964 · Marlo Surgical Technology · Oct 1991
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
K911180 · Northgate Technologies, Inc. · Mar 1991
GALL STONE FORCEPS
K890369 · Kinetic Medical Products · Feb 1989
HEMORRHOIDAL FORCEPS
K890373 · Kinetic Medical Products · Feb 1989