Atlas FDA

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k) clearance K014002 · decided 2002-03-04

Clearance details

K-number
K014002
Device name
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
Applicant
Fortune Medical Instrument Corp.
Decision
Substantially Equivalent
Date received
2001-12-04
Decision date
2002-03-04
Days to decision
90 days
Clearance type
Traditional
Product code
KOB
Device class
2
Regulation number
876.5090
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Taipei Hsien, TW
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.