510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K943031Substantially Equivalent

Bipolar Electrosurgical Pencil

Boston Surgical Products, Inc., Kingston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943031 is the FDA 510(k) clearance record for BIPOLAR ELECTROSURGICAL PENCIL, a class II device, cleared for Boston Surgical Products, Inc. on under FDA product code HQO (Unit, Cautery, Thermal, Ac-Powered). FDA records list 17 510(k) clearances for Boston Surgical Products, Inc., from to . As of , FDA records show no recalls naming K943031.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HQO Unit, Cautery, Thermal, Ac-Powered
Regulation
21 CFR 886.4115
Device class
Class II
Review panel
Ophthalmic
Applicant
Boston Surgical Products, Inc. 203 Indian Pond Rd., Kingston MA
510(k) summary
Statement
Third party review
No

Clearances, product code HQO

Trailing 12 months

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

FDA records show no clearances under product code HQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQO, 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