# K992137: Urological Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Apogee, Inc.
- Decided: Sep 3, 1999 after 71 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160795: United Urologics Intermittent Catheter (2016), 0 descendants of its own

## Recalls of this device
- Jul 17, 2008 · Not classified · Z-2390-2008: Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- Jul 17, 2008 · Not classified · Z-2394-2008: Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- Jul 17, 2008 · Not classified · Z-2392-2008: Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- Jul 17, 2008 · Not classified · Z-2391-2008: Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.
- Jul 17, 2008 · Not classified · Z-2393-2008: Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

## Indications for use
The Apogee Medical, Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder

Source page: https://510kreport.com/device/K992137
Methodology: https://510kreport.com/methodology