Product code HWQ
- Device name
- Passer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- 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 |
|---|---|---|---|
| K970360 | MITEK SUTURE RETROGRADER | Mitek Products | 1997-03-10 |
| K920621 | ACUFEX PASSING PINS AND SURGICAL WIRE | Acufex Microsurgical, Inc. | 1993-05-05 |
| K923381 | SOFT TISSUE EXPANDER | Acufex Microsurgical, Inc. | 1993-05-05 |
| K885311 | MENISCUS MENDER II LOOP | Instrument Makar, Inc. | 1989-02-09 |
| K843592 | VICO MICRO SURGICAL INSTRUMENTS | Visitec Co. | 1984-10-05 |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 |
| K811679 | SILASTIC TENDON PASSER H.P. | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
| K791960 | ROTH-KENNEDY PASSER | 3M Company | 1979-10-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10818674022207 | Suture passe | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-04-14 |
| 10850067560194 | LaproClose | Surgical Principals, Inc | 2025-12-11 |
| 10850067560187 | LaproClose | Surgical Principals, Inc | 2025-12-11 |
| 10850067560170 | LaproClose | Surgical Principals, Inc | 2025-12-11 |
| 10888277390454 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277388925 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277387966 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277387546 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277387539 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277386426 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277383586 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277382428 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-02-21 |
| 10888277387430 | MEDLINE RENEWAL | MEDLINE INDUSTRIES, INC. | 2025-02-14 |
| 10888277388017 | MEDLINE RENEWAL | MEDLINE INDUSTRIES, INC. | 2025-01-14 |
| 07899258662626 | Suture Fisher Hip | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662572 | Suture Fisher | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662589 | Suture Fisher | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662596 | Suture Fisher | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662602 | Suture Fisher Hip | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662619 | Suture Fisher Hip | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662633 | Caplock | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662640 | Caplock | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 07899258662657 | Suture Passer | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-06-19 |
| 10888277387812 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-09 |
| 10381780185260 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-29 |
| 10381780185277 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-29 |
| 10886982198198 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10810190018375 | Suture Passer Straight | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190015503 | Champion Slider Handle | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |
| 10810190018382 | Suture Passer 35° Up | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |