Cleared Traditional

PEEWEE REPLACEMENT GASTROSTOMY TUBE

K903662 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
Dec 1990
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K903662 is an FDA 510(k) clearance for the PEEWEE REPLACEMENT GASTROSTOMY TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on December 12, 1990, 121 days after receiving the submission on August 13, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K903662 FDA.gov
FDA Decision Cleared SESK
Date Received August 13, 1990
Decision Date December 12, 1990
Days to Decision 121 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

Similar Devices — KNT Tubes, Gastrointestinal (and Accessories)

All 648
XNY Disposable Gastric Calibration Tube
K250389 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · Apr 2025
Flexi-Seal AIR (with ENFit Connector)
K243228 · Convatec · Mar 2025
hygh-tec Drainage II
K242336 · Amb Medtec · Jan 2025
ZZIREN? Orogastric Tube; ZZIREN? SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN? SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN? SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN? GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN? GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN? GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
K242901 · Tools For Surgery, LLC · Jan 2025
Entarik NI Feeding Tube System
K241169 · Gravitas Medical, Inc. · Nov 2024
CORGRIP* SR NG/NI Tube Retention System
K241185 · Avanos Medical, Inc. · Oct 2024