Product code FBM
- Device name
- Cannula And Trocar, Suprapubic, Non-Disposable
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5090
- Review panel
- GU
- 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 |
|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Snowden-Pencer | 1996-03-12 |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Core Dynamics, Inc. | 1994-01-11 |
| K911813 | ENTREE CANNULA | Core Dynamics, Inc. | 1991-07-19 |
| K900955 | GS-4000 REDUCER SLEEVE, 11MM TO 5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900964 | CANNULA AND TROCAR, 11MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Solos Endoscopy, Inc. | 1990-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10653405045021 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10653405045038 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10653405045069 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10653405045083 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10653405045090 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10653405045007 | CORE DYNAMICS | Conmed Corporation | 2026-03-24 |
| 10801334012007 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007928 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10653405045861 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10653405045809 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10653405045786 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10653405045403 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10653405045397 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10885403155857 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155840 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155833 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155826 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155819 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155802 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155796 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155703 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155680 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155673 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155666 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155659 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155642 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155635 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155628 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155611 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |
| 10885403155604 | V. Mueller | CAREFUSION 2200, INC | 2016-09-23 |