510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252584Substantially Equivalent

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Weyo Surgical Technology, Ltd., Nanjing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252584 is the FDA 510(k) clearance record for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C), a class II device, cleared for Weyo Surgical Technology , Ltd. on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list one 510(k) clearance for Weyo Surgical Technology , Ltd. As of , FDA records show no recalls naming K252584.

Clearance record

Decision date
Received
(314 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Weyo Surgical Technology , Ltd. Rm. 313, Bldg. 3, 56 Ling Zhi Rd., Xuan Wu District, Nanjing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260