510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945861Substantially Equivalent

Bergen 710 Esu

Bergen Mfg., New Port Richey FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945861 is the FDA 510(k) clearance record for BERGEN 710 ESU, a class II device, cleared for Bergen Mfg. on under FDA product code HAM (Apparatus, Electrosurgical). FDA records list 4 510(k) clearances for Bergen Mfg., from to . As of , FDA records show no recalls naming K945861.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HAM Apparatus, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bergen Mfg. 9345 Rookery Rd., New Port Richey FL
510(k) summary
Summary
Third party review
No

Clearances, product code HAM

Trailing 12 months

FDA records hold no clearances under product code HAM in the trailing twelve months.

FDA records show no clearances under product code HAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260