Cleared Special

K050671 - ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM

K050671 is an FDA 510(k) clearance for ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM, manufactured by Surgrx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 17-day FDA review.

K050671 · Surgrx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
17d
Days
Class 2
Risk

K050671 is an FDA 510(k) clearance for the ENSEAL VESSEL SEALING & HEMOSTASIS 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 Surgrx, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 1, 2005 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050671

510(k) Number K050671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date April 01, 2005
Days to Decision 17 days
Submission Type Special
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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 2233
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K050671.
NON-STICK ELECTRODE
K043036 · Modern Medical Equipment Mfg., Ltd. · May 2005
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
K050831 · Stellartech Research Corp. · Apr 2005
SURGITRON RADIOLASE II
K042710 · Ellman Int'L, Inc. · Apr 2005
NEOTHERMIA EN-BLOC BIOPSY SYSTEM
K050737 · Neothermia Corporation · Mar 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · Megadyne Medical Products, Inc. · Mar 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · Boston Scientific Corp · Mar 2005
K050671 · ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
Download PDF FDA Summary Surgrx, Inc.