Cleared Traditional

K771639 - ELECTROSURGICAL GENERATOR

K771639 is the FDA 510(k) clearance for ELECTROSURGICAL GENERATOR by Cameron-Miller, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K771639 · Cameron-Miller, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
95d
Days
Class 2
Risk

K771639 is an FDA 510(k) clearance for the ELECTROSURGICAL GENERATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Cameron-Miller, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1977 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cameron-Miller, Inc. devices

Submission Details

510(k) Number K771639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1977
Decision Date November 29, 1977
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
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 1141
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K771639.
ELECTRO-SURGICAL GROUNDING PAD
K780298 · Johnson & Johnson Professionals, Inc. · Feb 1978
GENERATOR, ELECTROSURGICAL
K780206 · Valleylab, Inc. · Feb 1978
CAUTERIES, HOT WIRE, DISP.
K772199 · Intermedics, Inc. · Dec 1977
ELECTROSURG. PATIENT GROUNDING PLATE
K771352 · C.R. Bard, Inc. · Oct 1977
ELECTROSURGICAL POWER GENERATORS
K771007 · Aspen Laboratories, Inc. · Sep 1977
DISP. ELECTROSURGERY PENCIL
K771751 · Edward Weck, Inc. · Sep 1977