Cleared Traditional

K965054 - PENCIL

K965054 is an FDA 510(k) clearance for PENCIL, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K965054 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
37d
Days
Class 2
Risk

K965054 is an FDA 510(k) clearance for the PENCIL. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 37 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 Megadyne Medical Products, Inc. devices

FDA 510(k) Submission Details - K965054

510(k) Number K965054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date January 24, 1997
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 1768
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K965054.
ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
K965007 · Oratec Interventions, Inc. · Feb 1997
STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
K963765 · Stryker Endoscopy · Jan 1997
VIDAMED MODEDL 7600 RF GENERATOR
K965061 · Vidamed, Inc. · Jan 1997
CTS MIDCAB/SVH BIPOLAR SCISSORS
K963930 · Cardiothoracic Systems, Inc. · Jan 1997
MINI-SYMM BIPOLAR COAGULATOR
K964143 · Valley Forge Scientific Corp. · Jan 1997
DAVIS BAYONET ELECTRODES
K964602 · Valleylab, Inc. · Jan 1997