Cleared Traditional

K915300 - A & EM MEDICAL ELECTROSURGICAL PENCIL/A...

K915300 is the FDA 510(k) clearance for A & EM MEDICAL ELECTROSURGICAL PENCIL/A... by Alto Development Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K915300 · Alto Development Corp. · General & Plastic Surgery device
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Feb 1992
Decision
89d
Days
Class 2
Risk

K915300 is an FDA 510(k) clearance for the A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Alto Development Corp. (Farmingdale, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 89 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 Alto Development Corp. devices

Submission Details

510(k) Number K915300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1991
Decision Date February 18, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
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 1140
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K915300.
MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15
K920071 · Medical Devices, Inc. · Jul 1992
MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
K915204 · Conmedcorp · Jun 1992
GENESIS ELECTROSURGICAL UNIT
K920185 · Conmedcorp · Apr 1992
DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)
K914910 · Davol, Inc. · Jan 1992
MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS
K914400 · Valleylab, Inc. · Oct 1991
LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE
K912637 · Dexide, Inc. · Oct 1991