600 or 1200 Ml. Enteral Bag Administration Set

Q: What is the product code of K901753?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.

FDA 510(k) K901753 · Chartermed, Inc.

Substantially Equivalent

510(k) numberK901753

Submission

Device name: 600 or 1200 Ml. Enteral Bag Administration Set
Applicant: Chartermed, Inc.
Lakewood, NJ, US
Received: April 16, 1990
Decision date: June 1, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KNT – Tubes, Gastrointestinal (And Accessories)
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5980
Specialty: Gastroenterology, Urology

Other 510(k)s with product code KNT

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K253514	Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional	C.R. Bard, Inc.	07/10/2026SE
K250389	XNY Disposable Gastric Calibration TubeKNT · Traditional	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	04/10/2025SE
K243228	Flexi-Seal AIR (with ENFit Connector)KNT · Traditional	Convatec	03/28/2025SE
K242336	hygh-tec Drainage IIKNT · Traditional	Amb Medtec	01/17/2025SE
K242901	ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional	Tools For Surgery, LLC	01/10/2025SE
K241169	Entarik NI Feeding Tube SystemKNT · Traditional	Gravitas Medical, Inc.	11/22/2024SE
K241185	CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional	Avanos Medical, Inc.	10/25/2024SE
K240965	CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional	Avanos Medical, Inc.	06/06/2024SE
K233591	StylusKNT · Traditional	Degania Silicone , Ltd.	05/31/2024SE

More from Degania Silicone , Ltd.

510(k)	Device	Decision
K973103	Chartermed Tpn-Eva BagsKPE · Traditional	11/24/1997SE
K902079	Admixture Container for Total Parenteral NutritionKPE · Traditional	10/29/1990SE
K902464	Chartermed Empty TPN Container - 100 ML CapacityKPE · Traditional	08/30/1990SE

Questions and answers

When was 600 or 1200 Ml. Enteral Bag Administration Set cleared by the FDA?

600 or 1200 Ml. Enteral Bag Administration Set (K901753) received a 510(k) decision of Substantially Equivalent on June 1, 1990, 46 days after the submission was received.

What is the product code of K901753?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.