Cleared Traditional

K052246 - MODIFICATION TO EN-BLOC BIOPSY SYSTEM

K052246 is an FDA 510(k) clearance for MODIFICATION TO EN-BLOC BIOPSY SYSTEM, manufactured by Neothermia Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K052246 · Neothermia Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
5d
Days
Class 2
Risk

K052246 is an FDA 510(k) clearance for the MODIFICATION TO EN-BLOC BIOPSY SYSTEM. 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 Corporation (Natick, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 5 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.

FDA 510(k) Submission Details - K052246

510(k) Number K052246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date August 22, 2005
Days to Decision 5 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 115d · This submission: 5d
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 2297
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K052246.
DR. OPPEL ST-501
K051956 · Sometech Incorporated · Sep 2005
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
K051831 · Applied Surgical, LLC · Sep 2005
CANADY PLASMA PROBES
K052035 · Canady Technology, LLC · Aug 2005
HABIB 4X
K051420 · Emcision , Ltd. · Aug 2005
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
K051644 · Valleylab · Aug 2005
CLARIS NON-STICK BIPOLAR FORCEPS
K051429 · Guenter Bissinger Medizintechnik GmbH · Jul 2005
K052246 · MODIFICATION TO EN-BLOC BIOPSY SYSTEM
Download PDF FDA Summary Neothermia Corporation