Product code GDH
- Device name
- Gouge, Surgical, General & Plastic Surgery
- 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 |
|---|---|---|---|
| K903419 | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-08-09 |
| K900487 | MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-02-09 |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K874879 | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE | United States Surgical, A Division of Tyco Healthc | 1987-12-17 |
| K842822 | CHERMEL BONE GOUGES | Cher Mel Corp. | 1984-08-02 |
| K760850 | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898506848232 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848249 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848287 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848294 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848317 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848324 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506850259 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506847549 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506848256 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| 07898506848263 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
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| 10381780184737 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
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| 10381780184751 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
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| 10381780184713 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780184706 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780184690 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780184683 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165613 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165620 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780165644 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |