Cleared Traditional

K020031 - EN-BLOC BIOPSY SYSTEM

K020031 is an FDA 510(k) clearance for EN-BLOC BIOPSY SYSTEM, manufactured by Neothermia Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K020031 · Neothermia Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
82d
Days
Class 2
Risk

K020031 is an FDA 510(k) clearance for the EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Neothermia Corp. (Natick, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 82 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 Neothermia Corp. devices

FDA 510(k) Submission Details - K020031

510(k) Number K020031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2002
Decision Date March 27, 2002
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
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 1205
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K020031.
GYRUS ENT SOMNOPLASTY GENERATOR
K020067 · Gyrus Ent LLC · Apr 2002
ENTEC PLASMA WANDS
K014290 · Arthrocare Corp. · Mar 2002
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K020622 · Arthrocare Corp. · Mar 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc. · Mar 2002
ARTHROCARE CONTROLLER
K020557 · Arthrocare Corp. · Mar 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc. · Mar 2002