Atlas FDA

GYNECARE TVT SECUR SYSTEM

FDA 510(k) clearance K052401 · decided 2005-11-28

Clearance details

K-number
K052401
Device name
GYNECARE TVT SECUR SYSTEM
Applicant
ETHICON, Inc.
Decision
Substantially Equivalent
Date received
2005-09-01
Decision date
2005-11-28
Days to decision
88 days
Clearance type
Traditional
Product code
PAH
Device class
2
Regulation number
878.3300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Somerville, NJ, 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.

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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
MINITAPE URETHRAL SLING (K091180)Mpathy Medical Devices, Ltd.2009-07-14
BOSTON SCIENTIFIC SURGICAL MESH (K081275)Boston Scientific Corp2008-08-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ETHIZIA (P240035)ETHICON, Inc.2025-12-15
INTERCEED™ Absorbable Adhesion Barrier (P880047/S068)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S127)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S122)ETHICON, Inc.2025-11-04
SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126)ETHICON, Inc.2025-10-09
GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067)ETHICON, Inc.2025-10-09
SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125)ETHICON, Inc.2025-09-24
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S066)ETHICON, Inc.2025-09-24