Cleared Abbreviated

K023733 - COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR

K023733 is an FDA 510(k) clearance for COA-COMP/M, manufactured by Ingenjorsfirman Bjorn Bergdahl AB. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K023733 · Ingenjorsfirman Bjorn Bergdahl AB · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
189d
Days
Class 2
Risk

K023733 is an FDA 510(k) clearance for the COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ingenjorsfirman Bjorn Bergdahl AB (Billdal, SE). The FDA issued a Cleared decision on May 14, 2003 after a review of 189 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ingenjorsfirman Bjorn Bergdahl AB devices

FDA 510(k) Submission Details - K023733

510(k) Number K023733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2002
Decision Date May 14, 2003
Days to Decision 189 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

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 1688
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K023733.
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · Codman & Shurtleff, Inc. · May 2003
THERMACOOL TC SYSTEM
K031046 · Thermage, Inc. · May 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285 · Megadyne Medical Products, Inc. · May 2003
ARTHROCARE PERCD SPINEWAND
K030954 · Arthrocare Corp. · Apr 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · Leonhard Lang GmbH · Apr 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · Radionics, Inc. · Apr 2003