510(k) K093112
- Device
- DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
- Applicant
- COLOPLAST MANUFACTURING US, LLC
- 510(k) number
- K093112
- Product code
- GAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-02-01
- Date received
- 2009-10-01
- Regulation
- 878.5010
- Classification name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANELL COLLEY
- Address
- 1601 W. River Rd. Minneapolis MN US 55411 55411
FDA Registration Numbers#
- 3038718579
- 3003639970
- 3004215117
- 9680794
- 1061124
- 3008483449
- 3012101664
- 3003595343
- 3010041511
- 3004944585
- 2031768
- 9710098
- 3010131137
- 9612501
- 3004111573
- 2030624
- 3012026312
- 3003267729
- 1531174
- 2320762
- 9611459
- 1054241
- 2183744
- 3006638824
- 1064514
- 3029901632
- 1064584
- 3017102971
- 3004117249
- 3013187142
- 3014273254
- 3004903580
- 3014615644
- 1062741
- 3043226252
- 1319639
- 3010452421
- 3015330532
- 1018470
- 3016678045
- 1043214
- 1064017
- 3012421607
- 3013354263
- 1219930
- 3013548553
- 3007791599
- 2210968
- 3014772181
- 3030733800
- 3004365956
- 3003910212
- 3004192065
- 3006562124
- 3013557562
- 3011689956
- 3016904853
- 1055236
- 2648623
- 3004845555
- 3011137372
- 2183301
- 3025431509
- 1066741
- 3009968482
- 3014579161
- 3009142291
- 3014279513
- 1320468
- 2246552
- 1423537
- 3007205024
- 1017294
- 3008912461
- 3011276344
- 3006425876
- 1000274611
- 3019807891
- 1721676
Source Documents#
Other 510(k) Records For Product Code GAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2026-03-27 |
| K233355 | Cypris eXact Suturing System | Cypris Medical | 2024-01-12 |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| K221280 | Vesseal | Lydus Medical , Ltd. | 2022-12-09 |
| K211178 | DURAMESH Mesh Suture | Msi | 2022-09-02 |
| K192953 | APTOS Threads – Polypropylene Surgical Sutures | Aptos, LLC | 2020-08-27 |
| K193530 | Deklene MAXX | Teleflex Medical | 2020-03-19 |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | 2019-06-14 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 |
| K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018-03-07 |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | 2018-02-15 |
| K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | 2017-08-29 |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | 2017-05-03 |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017-04-06 |
| K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016-09-15 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases