Cleared Traditional

K010465 - DENSTAT

K010465 is an FDA 510(k) clearance for DENSTAT, manufactured by Elmed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K010465 · Elmed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
87d
Days
Class 2
Risk

K010465 is an FDA 510(k) clearance for the DENSTAT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on May 14, 2001 after a review of 87 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 Elmed, Inc. devices

FDA 510(k) Submission Details - K010465

510(k) Number K010465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2001
Decision Date May 14, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 1259
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K010465.
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · Ortho Development Corp. · Aug 2001
ENTEC EVAC PLASMA WAND
K011279 · Arthrocare Corp. · Jul 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · Arthrocare Corp. · Jun 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · Boston Scientific Corp · Apr 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS
K002000 · Richard Wolf Medical Instruments Corp. · Apr 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
K002981 · Ethicon Endo-Surgery, Inc. · Apr 2001