Atlas FDA

MINITAPE URETHRAL SLING

FDA 510(k) clearance K091180 · decided 2009-07-14

Clearance details

K-number
K091180
Device name
MINITAPE URETHRAL SLING
Applicant
Mpathy Medical Devices, Ltd.
Decision
Substantially Equivalent
Date received
2009-04-23
Decision date
2009-07-14
Days to decision
82 days
Clearance type
Special
Product code
PAH
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Glasgow, GB
Third-party review
No
Expedited review
No

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Similar devices under this product code

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Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack (K191416)Caldera Medical, Inc.2020-02-07
ALTIS SINGLE INCISION CLING SYSTEM (K121562)Coloplast A/S2012-11-05
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (K123179)C.R. Bard, Inc.2012-11-02
MINIARC PRO SINGLE-INCISION SLING SYSTEM (K121641)American Medical Systems2012-09-07
OPHIRA MINI SLING SYSTEM (K110420)Promedon S.A2012-05-08
DESARA MINI (K103418)Caldera Medical, Inc.2011-11-30
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (K100807)American Medical Systems, Inc.2010-06-07
AJUST ADJUSTABLE SINGLE INCISION SLING (K092607)C.R. Bard, Inc.2009-11-20
BOSTON SCIENTIFIC SURGICAL MESH (K081275)Boston Scientific Corp2008-08-27
MINITAPE URETHRAL SLING (K073646)Mpathy Medical Devices, Ltd.2008-02-25

Recalls involving this device

No recalls on record reference this clearance.