Cleared Traditional

K043383 - N-DO ENDOINJECTOR NEEDLE

K043383 is an FDA 510(k) clearance for N-DO ENDOINJECTOR NEEDLE, manufactured by Physion, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K043383 · Physion, Inc. · Gastroenterology & Urology device
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Oct 2005
Decision
322d
Days
Class 2
Risk

K043383 is an FDA 510(k) clearance for the N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Physion, Inc. (Short Hills, US). The FDA issued a Cleared decision on October 27, 2005 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Physion, Inc. devices

FDA 510(k) Submission Details - K043383

510(k) Number K043383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2004
Decision Date October 27, 2005
Days to Decision 322 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 130d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K043383.
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · Wilson-Cook Medical, Inc. · Jul 2011
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · Coloplast A/S · Apr 2009
INJEKT FILIFORM INJECTION NEEDLE
K082319 · Cook Urological, Inc. · Sep 2008
TEGRESS IMPLANT NEEDLE
K050688 · C.R. Bard, Inc. · Apr 2005
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
COOK INJECTION NEEDLE
K022484 · Cook Urological, Inc. · Oct 2002