510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192637Substantially Equivalent

High Strength Suture

Yunyi (Beijing) Medical Device Co., Ltd., Beijing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192637 is the FDA 510(k) clearance record for High Strength Suture, a class II device, cleared for Yunyi (Beijing) Medical Device Co., Ltd. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 2 510(k) clearances for Yunyi (Beijing) Medical Device Co., Ltd., from to . As of , FDA records show no recalls naming K192637.

Clearance record

Decision date
Received
(160 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Yunyi (Beijing) Medical Device Co., Ltd. Floor 1-4, Bldg. 4, # 9 Tianfu St.,, Beijing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

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