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FDA 510(k)

NEOMED ORAL/ENTERAL SYRINGE

K-Number: K122373 · 2012-09-20

ApplicantNeomed, Inc.
Decision Date2012-09-20
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOMED ORAL/ENTERAL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Neomed, Inc.. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K122373. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOMED ORAL/ENTERAL SYRINGE?

NEOMED ORAL/ENTERAL SYRINGE is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Neomed, Inc.. The 510(k) number is K122373.

When did NEOMED ORAL/ENTERAL SYRINGE receive FDA 510(k) clearance?

NEOMED ORAL/ENTERAL SYRINGE received FDA 510(k) clearance on 2012-09-20, under 510(k) number K122373.

Who is the listed applicant for NEOMED ORAL/ENTERAL SYRINGE?

The FDA 510(k) record lists Neomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOMED ORAL/ENTERAL SYRINGE?

The FDA product code for NEOMED ORAL/ENTERAL SYRINGE is FMF.

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Other records listing Neomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)K120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESK100288NEOMED ENTERAL ONLY EXTENSION SETK092908NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EOK082238NEOMED POLYURETHANE FEEDING TUBE

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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