510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972749Substantially Equivalent

Pao Bipolar Coaxial Coagulator (55-P15c/55-P18c/55-P18s/55-P19s/55-P20s)

C.M. Chance, Ltd., Southampton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972749 is the FDA 510(k) clearance record for PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S), a class II device, cleared for C.M. Chance , Ltd. on under FDA product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered). FDA records list one 510(k) clearance for C.M. Chance , Ltd. As of , FDA records show no recalls naming K972749.

Clearance record

Decision date
Received
(233 days to decision)
Product code
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
Regulation
21 CFR 886.4100
Device class
Class II
Review panel
Ophthalmic
Applicant
C.M. Chance , Ltd. 1018 St. Rd., Suite 201, Southampton PA
510(k) summary
Statement
Third party review
No

Clearances, product code HQR

Trailing 12 months

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

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