510(k) K091018
- Device
- ARTHREX BIOWIRE
- Applicant
- ARTHREX, INC.
- 510(k) number
- K091018
- Product code
- GAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-30
- Date received
- 2009-04-09
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyester
- 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
- SALLY FOUST
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers#
- 1320468
- 1220246
- 3013187142
- 1000274611
- 1064017
- 3015207155
- 2528981
- 3006981798
- 3007205024
- 3015231789
- 1064514
- 3008812560
- 2246552
- 3004944585
- 3019807891
- 1221601
- 1721676
- 3016851379
- 1061927
- 1825034
- 3007109793
- 3010400367
- 3013176080
- 3008114965
- 3014004349
- 3005941719
- 1221934
- 3010331645
- 3009513193
- 3035366890
- 1048735
- 1219602
- 3011137372
- 1226183
- 3008868758
- 3014273254
- 3018052045
- 3010041511
- 1017294
- 3004365956
- 1062741
Source Documents#
Other 510(k) Records For Product Code GAS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | 2020-11-24 |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | Lsi Solutions, Inc. | 2020-11-24 |
| K002261 | MR-III | Smith & Nephew, Inc. | 2000-10-23 |
| K953128 | SUTURE CORD | Phoenix Biomedical Corp. | 1996-02-09 |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | 1992-12-30 |
| K913101 | PETERS CARDIOFLON(TM) SUTURE | Promedica Products, Inc. | 1992-08-12 |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-02-03 |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-01-31 |
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | Advance Suture, Inc. | 1991-07-26 |
| K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 |
| K905440 | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1991-01-31 |
| K904535 | LU-TEX II | Lukens Medical Corp. | 1991-01-30 |
| K904436 | QUICKANCHOR (TM) | Mitek Surgical Products, Inc. | 1990-12-11 |
| K904263 | DACRON R SURGICAL SUTURES | Sharppoint, Inc. | 1990-10-16 |
| K904054 | POLYVIOLENE(TM) SUTURE | Look, Inc. | 1990-10-03 |
Legacy Summary#
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FDA Review#
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