510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182656Substantially Equivalent

JAMBRO Single Core A Sterilization wrap

Jiangsu Zhande Medical Supplies Co., Ltd., Nanjing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182656 is the FDA 510(k) clearance record for JAMBRO Single Core A Sterilization wrap, a class II device, cleared for Jiangsu Zhande Medical Supplies Co., Ltd. on under FDA product code FRG (Wrap, Sterilization). FDA records list one 510(k) clearance for Jiangsu Zhande Medical Supplies Co., Ltd. As of , FDA records show no recalls naming K182656.

Clearance record

Decision date
Received
(259 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Jiangsu Zhande Medical Supplies Co., Ltd. Nanjing Binjiang Economic Development Park, Nanjing, CN
510(k) summary
Summary PDF
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