Cleared Traditional

Female IC (Not Finalized) (K213575) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213575 · Hollister Incorporated · Gastroenterology & Urology device
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Sep 2022
Decision
307d
Days
Class 2
Risk

K213575 is an FDA 510(k) clearance for the Female IC (Not Finalized). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on September 13, 2022 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hollister Incorporated devices

Submission Details

510(k) Number K213575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2021
Decision Date September 13, 2022
Days to Decision 307 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
177d slower than avg
Panel avg: 130d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZD Catheter, Straight

All 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K213575.
Self-Cath and Self-Cath Plus
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Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
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SpeediCath Flex Set
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BONREE Nelaton Catheter
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SpeedCath Compact Male
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SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
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