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510(k) K120182

NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES by Neomed, Inc. — Product Code KNT

K120182 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 19, 2012. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Neomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2012
Date Received
January 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Neomed, Inc.

  • K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/E (April 30, 2019)
  • K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoC (June 17, 2016)
  • K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure (December 17, 2015)
  • K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector (April 9, 2015)
  • K122373 — NEOMED ORAL/ENTERAL SYRINGE (September 20, 2012)
  • K100288 — NEOMED ENTERAL ONLY EXTENSION SET (August 3, 2010)
  • K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD (March 10, 2010)
  • K082238 — NEOMED POLYURETHANE FEEDING TUBE (October 1, 2008)
  • K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (July 21, 2008)
  • K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER (February 22, 2008)

Other clearances for product code KNT

  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • K250389 — XNY Disposable Gastric Calibration Tube (April 10, 2025)
  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)

FDA data resources