510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260197Substantially Equivalent

Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)

Suzhou Shenyun Medical Equipment Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260197 is the FDA 510(k) clearance record for Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B), a class II device, cleared for Suzhou Shenyun Medical Equipment Co., Ltd. on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list one 510(k) clearance for Suzhou Shenyun Medical Equipment Co., Ltd. As of , FDA records show no recalls naming K260197.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GCJ Laparoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Suzhou Shenyun Medical Equipment Co., Ltd. Bldg. 11, # 666, Yinzang Rd., Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GCJ

Trailing 12 months
27 clearances under product code GCJ in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code GCJ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20263
February 20264
March 20260
April 20263
May 20264
June 20264
July 20263
August 20262
September 20262
October 20260