Cleared Special

K043008 - SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM

K043008 is an FDA 510(k) clearance for SURGRX ENSEAL VESSEL SEALING & HEMOSTAS..., 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 16-day FDA review.

K043008 · Surgrx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
16d
Days
Class 2
Risk

K043008 is an FDA 510(k) clearance for the SURGRX 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 November 17, 2004 after a review of 16 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 - K043008

510(k) Number K043008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date November 17, 2004
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 K043008.
SERFAS ENERGY SYSTEM
K041810 · Stryker Endoscopy · Dec 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
K043291 · Medtronic Vascular · Dec 2004
SMOKE EVACUATION ATTACHEMENT
K033095 · Modern Medical Equipment Mfg., Ltd. · Nov 2004
COOL-TIP RF ABLATION SYSTEM
K042216 · Valleylab · Nov 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
K042909 · Stellartech Research Corp. · Nov 2004
GENICON BIPOLAR FORCEPS MODEL # 600-005-005
K041968 · Genicon · Nov 2004
K043008 · SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
Download PDF FDA Summary Surgrx, Inc.