510(k) K221767
- Device
- Surgical Sutures with or without Needle
- Applicant
- Huaian Seamen Medical Technology Co., Ltd.
- 510(k) number
- K221767
- Product code
- GAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-31
- Date received
- 2022-06-17
- 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
- Xinjie Zhang
- Address
- # 6, Wangyuan Pioneer Park (Qunli Rd.) Yanhee St. Office Huaian CN 223008 223008
FDA Registration Numbers#
- 3014262693
- 1423537
- 3006425876
- 3006981798
- 3015330532
- 1064514
- 3015974593
- 3003639970
- 3013700547
- 3016851379
- 3019269298
- 2648623
- 3010400367
- 3017196117
- 3014004349
- 9616088
- 3009968482
- 3018094310
- 3010331645
- 1048735
- 3020983460
- 2530154
- 1054241
- 3006562124
- 9611459
- 3004117249
- 3018052045
- 3004192065
- 3007791573
- 1018470
- 9710098
- 1000274611
- 1219930
- 3027339877
- 3015231789
- 3015183635
- 3016426842
- 3014592276
- 3017102971
- 3013403214
- 3038718579
- 1055236
- 1221601
- 3004111573
- 3003267729
- 3010864832
- 1061927
- 3010692967
- 2521877
- 3011230048
- 3009513193
- 3010162973
- 3015859709
- 3021226419
- 1061124
- 3011276344
- 3014273254
- 3043226252
- 1221051
- 3007109793
- 1017294
- 3004365956
- 1220246
- 3013187142
- 3029901632
- 3003418325
- 3030733800
- 3007205024
- 3016904853
- 1043214
- 2320762
- 3012101664
- 3004215117
- 2210968
- 3012329552
- 3002579136
- 3010452421
- 1054811
- 3013298431
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 |
| 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 |
| K024091 | SILK SUTURES | Aurolab | 2003-02-28 |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | 2002-11-25 |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 |