Cleared Traditional

K902642 - CONTORNO (TM)

K902642 is the FDA 510(k) clearance for CONTORNO (TM) by Palex Intl. SA. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K902642 · Palex Intl. SA · General & Plastic Surgery device
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Aug 1990
Decision
54d
Days
Class 2
Risk

K902642 is an FDA 510(k) clearance for the CONTORNO (TM). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Palex Intl. SA (Spain, ES). The FDA issued a Cleared decision on August 7, 1990 after a review of 54 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 Palex Intl. SA devices

Submission Details

510(k) Number K902642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date August 07, 1990
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 893
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K902642.
VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE
K905529 · Valleylab, Inc. · Feb 1991
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · Valleylab, Inc. · Dec 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · Valleylab, Inc. · Dec 1990
WECK ELECTROSURGICAL GENERATOR #174200
K902232 · Edward Weck, Inc. · Aug 1990
SD SNARES
K902735 · Olympus Corp. · Aug 1990
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · 3M Company · Feb 1990