Cleared Traditional

K942499 - INSULATED SURGICAL ELECTRODE

K942499 is an FDA 510(k) clearance for INSULATED SURGICAL ELECTRODE, manufactured by Springfield Surgical Instruments. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K942499 · Springfield Surgical Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
38d
Days
Class 2
Risk

K942499 is an FDA 510(k) clearance for the INSULATED SURGICAL ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Springfield Surgical Instruments (Brimfield, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 38 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 Springfield Surgical Instruments devices

FDA 510(k) Submission Details - K942499

510(k) Number K942499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1994
Decision Date July 01, 1994
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 1965
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K942499.
BIOPLAR FORCEPS
K943231 · Cook Urological, Inc. · Jul 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE
K942489 · Megadyne Medical Products, Inc. · Jul 1994
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
K942892 · Conmedcorp · Jul 1994
SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE
K941426 · Symbiosis Corp. · Jun 1994
CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION
K932632 · Stephen Chakoff, Inc. · Jun 1994
KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION
K936036 · KARL STORZ Endoscopy-America, Inc. · Jun 1994