510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203613Substantially Equivalent

ENFit Reusable Enteral Syringe

Shantou Wealy Medical Instrument Co., Ltd., Shantou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203613 is the FDA 510(k) clearance record for ENFit Reusable Enteral Syringe, a class II device, cleared for Shantou Wealy Medical Instrument Co.,Ltd on under FDA product code PNR (Enteral Syringes With Enteral Specific Connectors). FDA's definition for product code PNR reads: "Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors". FDA records list 6 510(k) clearances for Shantou Wealy Medical Instrument Co.,Ltd, from to . As of , FDA records show no recalls naming K203613.

Clearance record

Decision date
Received
(260 days to decision)
Product code
PNR Enteral Syringes With Enteral Specific Connectors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Shantou Wealy Medical Instrument Co.,Ltd North Jinhuan Rd. (Near Qishan Mid-School),, Shantou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNR

Trailing 12 months
2 clearances under product code PNR 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 PNR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260