Cleared Traditional

K945861 - BERGEN 710 ESU

K945861 is an FDA 510(k) clearance for BERGEN 710 ESU, manufactured by Bergen Mfg.. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945861 · Bergen Mfg. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
90d
Days
Class 2
Risk

K945861 is an FDA 510(k) clearance for the BERGEN 710 ESU. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Bergen Mfg. (New Port Richey, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 90 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.

FDA 510(k) Submission Details - K945861

510(k) Number K945861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date March 01, 1995
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAM Device Classification - Class 2, Special Controls

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - HAM Apparatus, Electrosurgical

All 15
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K945861.
Quiver Laparoscopic Extendable
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K945861 · BERGEN 710 ESU
Download PDF FDA Summary Bergen Mfg.