Cleared Traditional

K010112 - BIPOLAR COAGULATION SYSTEM

K010112 is an FDA 510(k) clearance for BIPOLAR COAGULATION SYSTEM, manufactured by Enable Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K010112 · Enable Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
80d
Days
Class 2
Risk

K010112 is an FDA 510(k) clearance for the BIPOLAR COAGULATION 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 Enable Medical Corp. (West Chester, US). The FDA issued a Cleared decision on April 2, 2001 after a review of 80 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 - K010112

510(k) Number K010112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2001
Decision Date April 02, 2001
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 2204
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K010112.
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
K003676 · Rita Medical Systems · Apr 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
K010265 · Baylis Medical Co., Inc. · Apr 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
K010010 · Valleylab, Inc. · Apr 2001
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
K010192 · Antyllos Medizintechnik GmbH · Apr 2001
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
K010013 · Valleylab, Inc. · Mar 2001
ENDIUS BIPOLAR SHEATH
K003897 · Endius, Inc. · Mar 2001
K010112 · BIPOLAR COAGULATION SYSTEM
Download PDF FDA Summary Enable Medical Corp.