510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811821Substantially Equivalent

Carotid Artery Clamp & Tools

New England Surgical Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811821 is the FDA 510(k) clearance record for CAROTID ARTERY CLAMP & TOOLS, a class II device, cleared for New England Surgical Instrument Corp. on under FDA product code HCE (Clamp, Carotid Artery). FDA records list 18 510(k) clearances for New England Surgical Instrument Corp., from to . As of , FDA records show no recalls naming K811821.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HCE Clamp, Carotid Artery
Regulation
21 CFR 882.5175
Device class
Class II
Review panel
Neurology
Applicant
New England Surgical Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HCE

Trailing 12 months

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

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