Cannula And Trocar, Suprapubic, Non-Disposable
The Non-Disposable Suprapubic Cannula and Trocar (product code FBM) is a reusable instrument set used to create a suprapubic access point through the abdominal wall to the bladder for drainage or surgical procedures. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.5090 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FBM
- Device Class
- FDA class 1
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Mar 12, 1996 | Substantially Equivalent | Snowden-Pencer |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Jan 11, 1994 | Substantially Equivalent | Core Dynamics, Inc. |
| K911813 | ENTREE CANNULA | Jul 19, 1991 | Substantially Equivalent | Core Dynamics, Inc. |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
| K900964 | CANNULA AND TROCAR, 11MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
| K900955 | GS-4000 REDUCER SLEEVE, 11MM TO 5MM | Apr 18, 1990 | Substantially Equivalent | Solos Endoscopy, Inc. |
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.