Cleared Traditional

K964736 - BERGEN 610 BIPOLAR COAGULATOR

K964736 is an FDA 510(k) clearance for BERGEN 610 BIPOLAR COAGULATOR, manufactured by Bergen Mfg.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K964736 · Bergen Mfg. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
94d
Days
Class 2
Risk

K964736 is an FDA 510(k) clearance for the BERGEN 610 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 Bergen Mfg. (New Port Richey, US). The FDA issued a Cleared decision on February 27, 1997 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bergen Mfg. devices

FDA 510(k) Submission Details - K964736

510(k) Number K964736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date February 27, 1997
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 1470
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K964736.
SELECTA-TIP LAPAROSCOPIC SCISSORS
K970826 · Microline Pentax, Inc. · Mar 1997
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
K964636 · Valleylab, Inc. · Mar 1997
BIPOLAR SUCTION COAGULATOR
K965241 · Kirwan Surgical Products, Inc. · Feb 1997
ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
K970039 · Medtrex, Inc. · Feb 1997
ENDOCARE ELECTROSURGICAL ELECTRODE
K965243 · Endocare, Inc. · Feb 1997
UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
K970066 · Unimed Surgical Products, Inc. · Feb 1997