Cleared Traditional

K770969 - CLEV-DENT COLHS ELECTROSURG

K770969 is the FDA 510(k) clearance for CLEV-DENT COLHS ELECTROSURG by Cavitron Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K770969 · Cavitron Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1977
Decision
24d
Days
Class 2
Risk

K770969 is an FDA 510(k) clearance for the CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 24 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 Cavitron Corp. devices

Submission Details

510(k) Number K770969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date June 24, 1977
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 895
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K770969.
CONDUCTIVE ELECTRODE GEL
K771331 · Edward Weck, Inc. · Sep 1977
PATIENT GROUNDING CABLES
K771332 · Edward Weck, Inc. · Sep 1977
MACBICK CONDUCTIVE GEL - 000907
K771440 · C.R. Bard, Inc. · Aug 1977
ELECTROSURGICAL GROUNDING CABLE
K770647 · C.R. Bard, Inc. · May 1977
ELECTROSURGICAL PATIENT GROUNDING PAD
K770646 · C.R. Bard, Inc. · Apr 1977