Cleared Traditional

K973110 - LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES

Also marketed or referenced as:
WITH AND WITHOUT CORD

K973110 is an FDA 510(k) clearance for LUDLOW TECHNICAL PRODUCTS, manufactured by Ludlow Technical Products. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K973110 · Ludlow Technical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
62d
Days
Class 2
Risk

K973110 is an FDA 510(k) clearance for the LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC D.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ludlow Technical Products (Chicopee, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ludlow Technical Products devices

FDA 510(k) Submission Details - K973110

510(k) Number K973110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date October 21, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1468
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K973110.
COSMAN COAGULATOR (CC-1) SYSTEM
K973297 · Radionics, Inc. · Oct 1997
MIDAS TOUCH ELECTROSURGICAL ELECTRODE
K973234 · Iti Medical Technologies, Inc. · Oct 1997
BOVIE MODEL X40
K972071 · Maxxim Medical · Oct 1997
BIPOLAR SCISSORS
K972558 · Enable Medical Corp. · Oct 1997
ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR
K973159 · Oratec Interventions, Inc. · Sep 1997
PIONEER ELEC-TROCAR DEVICE
K971728 · Pioneer Surgical Technology · Sep 1997