Cleared Traditional

K926306 - FOOT CONTROL PENCIL

K926306 is the FDA 510(k) clearance for FOOT CONTROL PENCIL by Megadyne Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K926306 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
52d
Days
Class 2
Risk

K926306 is an FDA 510(k) clearance for the FOOT CONTROL 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. (Murray, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 52 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

Submission Details

510(k) Number K926306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date February 05, 1993
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1136
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K926306.
GRASPERS & SCISSORS (MINIMAL ACCESS SURG INSTR)
K924469 · Conmedcorp · Apr 1993
FORCE GSU(TM) HANDSET W/3 & 6 FLEXIBLE EXTENDER
K924524 · Valleylab, Inc. · Apr 1993
NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)
K925130 · Laserscope · Mar 1993
FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)
K924918 · Valleylab, Inc. · Jan 1993
SYMBIOSIS SUCTION-IRRIGATOR
K923563 · Symbiosis Corp. · Nov 1992
DEXIDE LAPAROSCOPIC ACCESSORIES
K923845 · Dexide, Inc. · Nov 1992