510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021166Substantially Equivalent

Acmi Bipolar Rectoscope, Model Eiwe-Br

Acmi-Circon Corporation, Southborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021166 is the FDA 510(k) clearance record for ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR, a class II device, cleared for Acmi-Circon Corporation on under FDA product code FDC (Resectoscope, Working Element). FDA records list one 510(k) clearance for Acmi-Circon Corporation. As of , FDA records show no recalls naming K021166.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FDC Resectoscope, Working Element
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Acmi-Circon Corporation 136 Turpike Rd., Southborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDC

Trailing 12 months

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

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