Cleared Traditional

K921800 - COLONOSCOPIC INJECTION NEEDLE

K921800 is the FDA 510(k) clearance for COLONOSCOPIC INJECTION NEEDLE by Mill-Rose Laboratory. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K921800 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Feb 1993
Decision
300d
Days
Class 2
Risk

K921800 is an FDA 510(k) clearance for the COLONOSCOPIC INJECTION NEEDLE, C-323/C-325. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 8, 1993 after a review of 300 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. Standard predicate reliance. 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.

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Submission Details

510(k) Number K921800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date February 08, 1993
Days to Decision 300 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 130d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K921800.
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
K941305 · Wilson-Cook Medical, Inc. · Jun 1994
BARD ENDOSCOPIC INJECTION SYSTEM
K933815 · C.R. Bard, Inc. · Dec 1993
NEEDLE
K924102 · United States Endoscopy Group, Inc. · Nov 1992
WILSON-COOK ASPIRATION HANDLE
K903668 · Wilson-Cook Medical, Inc. · Oct 1990
NM INJECTION NEEDLES
K902736 · Olympus Corp. · Aug 1990