510(k) K173644
- Device
- Gazelle Polypropylene Suture And Delivery Device
- Applicant
- Dura Tap LLC
- 510(k) number
- K173644
- Product code
- GAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-15
- Date received
- 2017-11-27
- Regulation
- 878.5010
- Classification name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ann R. Lee
- Address
- 208 Upland Way Wayne PA US 19087 19087
FDA Registration Numbers#
- 1423537
- 3006425876
- 2528981
- 3006981798
- 3015330532
- 1064514
- 3003639970
- 3009142291
- 2648623
- 3017196117
- 9616088
- 3009968482
- 3018094310
- 3020983460
- 1319639
- 1054241
- 3006562124
- 9611459
- 3004117249
- 3018052045
- 3004903580
- 3004192065
- 1320468
- 1018470
- 9710098
- 1000274611
- 1219930
- 3013188547
- 3016426842
- 3025431509
- 3014592276
- 3017102971
- 3013403214
- 3038718579
- 1055236
- 1221601
- 3004111573
- 3003267729
- 3010864832
- 3010692967
- 3003910212
- 3009513193
- 1061124
- 3011276344
- 3014273254
- 3043226252
- 1017294
- 3004365956
- 3004060107
- 3013187142
- 3016678045
- 2031768
- 3029901632
- 3030733800
- 3007205024
- 3016904853
- 1043214
- 2320762
- 3012101664
- 3004215117
- 2246552
- 2210968
- 3013354263
- 3010452421
- 3013298431
- 2648650
- 3019807891
- 3004845555
- 9617547
- 2183301
- 9612501
- 3003595343
- 3013517171
- 3010131137
- 1064584
- 3012494290
- 3014461810
- 2032098
- 3010041511
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 |
| 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 |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | Resorba Medical GmbH | 2015-10-29 |
Legacy Summary#
summary
FDA Review#
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