Cleared Traditional

K061222 - INJECTRA INJECTION NEEDLE

K061222 is an FDA 510(k) clearance for INJECTRA INJECTION NEEDLE, manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K061222 · Medi-Globe Corp. · Gastroenterology & Urology device
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Jul 2006
Decision
62d
Days
Class 2
Risk

K061222 is an FDA 510(k) clearance for the INJECTRA INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 62 days - a notably fast clearance cycle.

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: 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 Medi-Globe Corp. devices

FDA 510(k) Submission Details - K061222

510(k) Number K061222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date July 03, 2006
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 131d · This submission: 62d
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 73
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K061222.
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