Product code HCF
- Device name
- Instrument, Ligature Passing And Knot Tying
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015-06-16 |
| K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | Boston Scientific Corp | 1993-07-13 |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | 1985-06-12 |
| K841617 | STROVER HOOK | Plastafil, Inc. | 1984-08-27 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | 1979-04-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198506091865 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-10 |
| 05060411982963 | Birks Tying Forceps 110mm, 5mm Platform with 0.3mm Tips | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411983021 | Crilewood Needle Holder 150mm | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411984486 | De Bakey Needle Holder 180mm | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411985032 | Castroviejo Needle Holder with Lock 145mm | DTR MEDICAL LIMITED | 2026-06-10 |
| 05060411986961 | Barraquer Needle Holder 120mm, Curved 12mm Jaws, non locking | DTR MEDICAL LIMITED | 2026-06-10 |
| 00198506091285 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00192896123441 | Barraquer Anis Needle Holder | SONTEC INSTRUMENTS, INC. | 2026-06-02 |
| G453521053112M0 | PEAK MEDICAL | Peak Medical Distribution Inc. | 2025-10-01 |
| 08904332600766 | Mediflex | ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED | 2025-05-19 |
| 07899258638614 | STA - Achilles Tendon Suture System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-12 |
| 04250407742294 | FENTEX | FENTEX medical GmbH | 2022-12-12 |
| 10840143904424 | Lariat RS | ATRICURE, INC. | 2021-07-29 |
| 10811955020718 | OverStitch Endoscopic Suturing System Sx | Apollo Endosurgery, Inc. | 2021-05-26 |
| 10840143901713 | Lariat RS | ATRICURE, INC. | 2021-01-11 |
| 09349967000540 | Suture PassOR | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000571 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000632 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000694 | Port ClosOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000519 | Suture PassOR | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967000366 | Suture PassOR Pro | THE O R COMPANY PTY LTD | 2019-03-26 |
| 10381780043294 | ACHILLON® | NEWDEAL | 2018-10-16 |
| 10381780043300 | ACHILLON® | NEWDEAL | 2017-10-05 |
| 10649111287893 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111288531 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111292880 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111293771 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111296703 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111297144 | Sklar® | SKLAR CORPORATION | 2017-06-21 |
| 10649111287282 | Sklar® | SKLAR CORPORATION | 2017-06-21 |