Cleared Traditional

K051281 - THE NEEDLE CATCHER

K051281 is an FDA 510(k) clearance for THE NEEDLE CATCHER, manufactured by E.D.Medical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K051281 · E.D.Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
114d
Days
Class 1
Risk

K051281 is an FDA 510(k) clearance for the THE NEEDLE CATCHER. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by E.D.Medical , Ltd. (Belfast, GB). The FDA issued a Cleared decision on September 8, 2005 after a review of 114 days - within the typical 510(k) review window.

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 E.D.Medical , Ltd. devices

FDA 510(k) Submission Details - K051281

510(k) Number K051281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date September 08, 2005
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
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 62
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K051281.
SEMKIN INSULATED BIPOLAR FORCEP
K974593 · Titan Mfg., Inc. · Jun 1998
SEMKIN BIPOLAR FORCEP
K974594 · Titan Mfg., Inc. · Jun 1998
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
K974595 · 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