510(k) K242571
- Device
- Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FC
- Applicant
- Hyundae Meditech Co., Ltd.
- 510(k) number
- K242571
- Product code
- NEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-27
- Date received
- 2024-08-29
- Regulation
- 878.4840
- Classification name
- Suture, Surgical, Absorbable, Polydioxanone
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Oh Ju-in
- Address
- 80, Cheongjeong-Ro, Jijeong-Myeon Wonju-Si KR 26347 26347
FDA Registration Numbers#
- 1614993
- 2528981
- 3006981798
- 3006680097
- 3003639970
- 3016560306
- 3012438919
- 3020983460
- 1054241
- 3016010820
- 3008868758
- 3006562124
- 3004117249
- 3018052045
- 1320468
- 1018470
- 1000274611
- 2125050
- 3027329031
- 3013589761
- 3015138222
- 3015289316
- 3017102971
- 3013403214
- 3015812758
- 1055236
- 3016244792
- 1221601
- 3023274465
- 3003267729
- 3010864832
- 3002294946
- 3010692967
- 1221934
- 3011555199
- 3003828812
- 3010462274
- 3016445763
- 3014273254
- 3043226252
- 3004365956
- 3013187142
- 3029901632
- 3030733800
- 3007205024
- 3016904853
- 3038138322
- 1043214
- 2246552
- 2210968
- 3013354263
- 3013298431
- 2648650
- 3004845555
- 3017936846
- 3005972890
- 3008114965
- 9617547
- 3013376016
- 3010131137
- 1064584
- 3012494290
- 3014527910
- 3014461810
- 3010041511
- 2650143
- 2183744
- 3014615644
- 3007791599
- 3014272734
- 3012502601
- 3004944585
- 3007895168
- 1721676
- 3006638824
- 2030624
- 3005953126
- 3011137372
- 3012421607
- 3008912461
Source Documents#
Other 510(k) Records For Product Code NEW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2026-05-18 |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2025-11-12 |
| K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025-10-20 |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | 2025-10-15 |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 |
| K250977 | Suture-TOOL System | Suturion AB | 2025-04-28 |
| K242835 | Suture-TOOL System | Suturion AB | 2025-01-22 |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | 2024-03-27 |
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | Hans Biomed Corporation | 2023-03-07 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | ETHICON, Inc. | 2022-02-22 |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | 2021-12-17 |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 |
| K192423 | MINT Product Family | Hans Biomed Corporation | 2020-09-09 |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020-03-25 |