Cleared Traditional

INSERTEASE (K092829) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K092829 · Christcot Medical Company · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
78d
Days
Class 1
Risk

K092829 is an FDA 510(k) clearance for the INSERTEASE. Classified as Applicator For Rectal Suppository (product code OOW), Class I - General Controls.

Submitted by Christcot Medical Company (Sudbury, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Christcot Medical Company devices

Submission Details

510(k) Number K092829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2009
Decision Date December 02, 2009
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OOW Applicator For Rectal Suppository
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
Definition Intended For Use In The Insertion Of Suppositories Into The Rectum
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.