Cleared Traditional

K891109 - PANDA NEEDLE CATHETER JEJUNOSTOMY TUBE

K891109 is an FDA 510(k) clearance for PANDA NEEDLE CATHETER JEJUNOSTOMY TUBE, manufactured by Concept, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K891109 · Concept, Inc. · Gastroenterology & Urology device
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May 1989
Decision
67d
Days
Class 2
Risk

K891109 is an FDA 510(k) clearance for the PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Concept, Inc. (Largo, US). The FDA issued a Cleared decision on May 8, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K891109

510(k) Number K891109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date May 08, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 300
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K891109.
PEDI-TUBE(R) STYLET
K894857 · Biosearch Medical Products, Inc. · Oct 1989
ENTERA-FLO SPIKE SET
K893209 · Delmed, Inc. · Jul 1989
KENDALL CURITY STOMACH TUBES
K892439 · The Kendal Co. · Jun 1989
BARD GASTROSTOMY FEEDING DEVICE
K890870 · C.R. Bard, Inc. · Apr 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · Abbott Laboratories · Dec 1988