510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K171857Substantially Equivalent

AMSure® Enteral Feeding Syringe with ENFit Tip

Amsino International, Inc., Pomona CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171857 is the FDA 510(k) clearance record for AMSure® Enteral Feeding Syringe with ENFit Tip, a class II device, cleared for Amsino International, Inc. 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 28 510(k) clearances for Amsino International, Inc., from to . As of , FDA records show no recalls naming K171857.

Clearance record

Decision date
Received
(282 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
Amsino International, Inc. 708 Corporate Center Dr., Pomona CA
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