510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193561Substantially Equivalent

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Weihai Xingtai Packaging Products Co., Ltd., Weihai, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K193561 is the FDA 510(k) clearance record for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch, a class II device, cleared for Weihai Xingtai Packaging Products Co., Ltd. on under FDA product code FRG (Wrap, Sterilization). FDA records list 2 510(k) clearances for Weihai Xingtai Packaging Products Co., Ltd., from to . As of , FDA records show no recalls naming K193561.

Clearance record

Decision date
Received
(114 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Weihai Xingtai Packaging Products Co., Ltd. Sunjiatan Industrial Zone, Yangting Town, Huancui Area, Weihai, CN
510(k) summary
Statement
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260