ClearanceBrief
Panels › General, Plastic Surgery › Product code OTN · Class 2

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Regulation 878.3300

1510(k)s in 12 months (66 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Get daily alerts for OTNSample briefCSV

Top companies in OTN

Company510(k)sRecalls
American Medical Systems141
Caldera Medical80
ETHICON, Inc.60
Boston Scientific50
Mentor Corp.40
Island Biosurgical, Inc.30
Urocure, LLC30
C.R. Bard, Inc.20
Generic Medical Device, Inc.20
Influence, Inc.20
Decided510(k)Device and applicantCode
Nov 19, 2002K023516MONARC SLING SYSTEM
American Medical Systems, Inc.
OTN
May 15, 2002K021263MODIFICATION TO SPARC SLING SYSTEM
American Medical Systems, Inc.
OTN
Apr 26, 2002K020705SIIS#1 TISSUE SUSPENSION SYSTEM
Tag Medical Products, IL
OTN
Apr 3, 2002K020110MODIFICATION TO TRELEX MESH SURGICAL MESH
Boston Scientific
OTN
Mar 28, 2002K020663MODIFICATION TO SPARC SLING SYSTEM
American Medical Systems, Inc.
OTN
Mar 21, 2002K020007SAFYRE SLING SYSTEM
Promedon
OTN
Oct 26, 2001K013355SPARC SLING SYSTEM
American Medical Systems, Inc.
OTN
Oct 26, 2001K012628GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
Gynecare Center
OTN
Oct 4, 2001K012949URETEX SUP PUBOURETHRAL SLING
Sofradim Production
OTN
Aug 1, 2001K011251SPARC SLING SYSTEM
American Medical Systems, Inc.
OTN
Sep 8, 1998K982042ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
Island Biosurgical, Inc.
OTN
Mar 27, 1998K980482TRIANGLE SLING
Influence, Inc.
OTN
Jan 28, 1998K974098PUBOUURETHRAL SLING
ETHICON, Inc.
OTN
Oct 20, 1997K973022ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
Island Biosurgical, Inc.
OTN
Sep 19, 1997K972651IN-SLING
Influence, Inc.
OTN
Dec 16, 1996K960101ISLAND BIOSURGICAL BOLSTER
Island Biosurgical, Inc.
OTN

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