510(k) K024091
- Device
- SILK SUTURES
- Applicant
- AUROLAB
- 510(k) number
- K024091
- Product code
- GAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-28
- Date received
- 2002-12-11
- Regulation
- 878.5030
- Classification name
- Suture, Nonabsorbable, Silk
- 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
- MICHAEL G PRICE
- Address
- 6441 Enterprise Ln. Suite 214 Madison WI US 53719 53719
FDA Registration Numbers#
- 3029901632
- 3013187142
- 3014004349
- 3007791599
- 3032543753
- 3021226419
- 1066741
- 1220246
- 3016426842
- 3015806723
- 3038718579
- 2030624
- 3015859709
- 3007791573
- 1219930
- 3011276344
- 3012502601
- 2521877
- 3012329552
- 3016904853
- 3010400367
- 1048735
- 1423537
- 3008912461
- 3006498370
- 1043214
- 1000274611
- 3016851379
- 3014615644
- 3013700547
- 3045855232
- 3044819802
- 3002579136
- 3018094310
- 3017196117
- 1037089
- 3011230048
- 3014579161
- 3027339877
- 3045857302
- 1221051
- 3011689956
- 3011137372
- 3015231789
- 3015974593
- 3019269298
- 3004845555
- 3007205024
- 1055236
- 3006981798
- 3010864832
- 1064017
- 3012101664
- 1054811
- 3017102971
- 9680794
- 9611459
- 3008483449
- 9710098
- 3002692886
- 3004117249
- 3004111573
- 2530154
- 2210968
- 3006562124
- 3006425876
- 3004192065
- 1018470
- 3010041511
- 2032098
- 9612501
- 9616088
- 3013298431
- 3015183635
- 3018052045
- 3004215117
- 1054241
- 3004365956
- 2183301
- 3020704423
Source Documents#
Other 510(k) Records For Product Code GAP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241486 | Sofsilk™ Coated Braided Silk Suture | Covidien | 2024-12-03 |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. | 2024-10-18 |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018-06-25 |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016-11-23 |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | 2016-05-31 |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-06-09 |
| K071111 | NON-ABSORBABLE SILK SUTURE | Arrow Intl., Inc. | 2007-07-17 |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | 2006-05-19 |
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 |
| K042282 | UNISILK | United Medical Industries Co. , Ltd. | 2004-12-01 |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | 2002-11-25 |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 |
Legacy Summary#
summary
FDA Review#
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