Atlas FDA

UROLOGICAL CATHETER

FDA 510(k) clearance K992137 · decided 1999-09-03

Clearance details

K-number
K992137
Device name
UROLOGICAL CATHETER
Applicant
Apogee, Inc.
Decision
Substantially Equivalent
Date received
1999-06-24
Decision date
1999-09-03
Days to decision
71 days
Clearance type
Traditional
Product code
GBM
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Raleigh, NC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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LotusCatheter (Lotus No Balloon Catheter) (K191512)Hakki Medical Technologies, Inc.2020-05-21
Actreen Hi-Lite Intermittent Urinary Catheters (K192577)B.Braun Medical, Inc.2020-05-07
VaPro Plus Pocket, VaPro Plus (K193148)Hollister Incorporated2019-12-13
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter (K192468)Hangzhou Bever Medical Devices Co., Ltd.2019-11-27
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Recalls involving this device

RecordFirmDate
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The dev recall (Z-2390-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The dev recall (Z-2391-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The de recall (Z-2392-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Lat recall (Z-2393-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Late recall (Z-2394-2008)Apogee Medical, Inc2008-09-21