Cleared Traditional

K791137 - SINGLE USE MONOPOLAR HAND CONTROL PENCIL

K791137 is the FDA 510(k) clearance for SINGLE USE MONOPOLAR HAND CONTROL PENCIL by Davol, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K791137 · Davol, Inc. · General & Plastic Surgery device
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Jul 1979
Decision
36d
Days
Class 2
Risk

K791137 is an FDA 510(k) clearance for the SINGLE USE MONOPOLAR HAND 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 Davol, Inc. (Walker, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 36 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 Davol, Inc. devices

Submission Details

510(k) Number K791137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1979
Decision Date July 24, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K791137.
MODEL E2515 ELECTROSURGICAL ACCESSORY
K791639 · Valleylab, Inc. · Sep 1979
ELECTROSURGICAL CUT AND COAGU ACCESSORY
K791362 · Intermedics, Inc. · Sep 1979
ELECTROSURGICAL GENERATOR (TIM)
K791230 · Concept, Inc. · Aug 1979
SAFETY HOLSTER, SINGLE-USE
K790770 · Aspen Laboratories, Inc. · May 1979
ELECTRODE, MODEL E7504 PREP II
K790296 · Valleylab, Inc. · Apr 1979
GRAB-IT
K790367 · Concept, Inc. · Mar 1979