Product code GAB
- Device name
- Needle, Suturing, Disposable
- 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 |
|---|---|---|---|
| K012199 | DIGICAP | Humana USA, Inc. | 2001-12-19 |
| K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | Axya Medical, Inc. | 1998-05-11 |
| K932591 | ENDO-JUDGE | Synergistic Medical Technologies, Inc. | 1993-12-22 |
| K895681 | CONTRAST BACKGROUND MATERIAL | Applied Medical Technologies | 1989-10-24 |
| K863595 | COATED SUTURE NEEDLE | Sharpoint, Inc. | 1986-10-24 |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | 1983-08-16 |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | 1981-12-14 |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | 1980-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850007280199 | Needle counter, 40-80 count, double foam, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 10850007280205 | Needle counter, 100 count, foam block, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 10850007280311 | Needle counter, 20 count, foam block, magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 30864887000062 | Needle counter, 20 count, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 30864887000079 | Needle counter, 30 count, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 30864887000093 | Needle counter, 40 count, foam block, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 10850007280182 | Needle counter, 30-60 count, double magnet, adhesive tabs | NEWGEN SURGICAL, INC. | 2026-10-15 |
| 09353903030225 | OCTOPi Suture Anchor System | FIELD ORTHOPAEDICS PTY LTD | 2026-07-15 |
| 09353903030201 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2026-06-24 |
| 10192253052275 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052268 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052251 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052244 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052237 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052220 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052213 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052206 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052190 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052183 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052176 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052169 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052152 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052145 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 10192253052138 | Devon | Cardinal Health 200, LLC | 2025-03-27 |
| 09353903030003 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2024-09-19 |
| 09337363001735 | BladeNeedleSYSTEM | QLICKSMART PTY LTD | 2019-11-27 |
| 09337363001728 | BladeNeedleSYSTEM | QLICKSMART PTY LTD | 2019-11-27 |
| 09337363001681 | BladeNeedleSYSTEM | QLICKSMART PTY LTD | 2019-11-27 |
| 09337363001674 | BladeNeedleSYSTEM | QLICKSMART PTY LTD | 2019-11-27 |
| 09337363000882 | BladeNeedleSYSTEM | QLICKSMART PTY LTD | 2017-08-22 |