Product code GDL
- Device name
- Needle, Suturing, Reusable
- 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 |
|---|---|---|---|
| K881394 | NON-STERILE SUTURE NEEDLES | China National Medicines C/O Havel'S | 1988-04-08 |
| K851781 | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | Artiberia | 1985-06-20 |
| K851782 | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | Artiberia | 1985-06-20 |
| K813589 | SHARTPOINT EYED NEEDLES | S. Jackson, Inc. | 1982-01-18 |
| K812566 | UNIVERSAL SUTURE PASSER | Ortho Pared Instruments, Inc. | 1981-11-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G586OP7121290 | Novo Surgical | NOVO SURGICAL, INC. | 2024-10-15 |
| M6335824880 | JEDMED | JEDMED INSTRUMENT COMPANY | 2023-01-19 |
| 14026704811547 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| ESAM4212141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4218081 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4218071 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4218061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4218051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4216161 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4216151 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4216131 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4214161 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4214151 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4214141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4214131 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4212161 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4216141 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4212151 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4212131 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 04038653140305 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140206 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140190 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140169 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140138 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140114 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140107 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653140091 | AESCULAP | Aesculap AG | 2020-04-21 |
| 04038653001804 | AESCULAP | Aesculap AG | 2020-04-17 |
| 04038653001613 | AESCULAP | Aesculap AG | 2020-04-17 |
| 10381780192787 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |