FBM · Cannula And Trocar, Suprapubic, Non-Disposable
Gastroenterology, Urology · 21 CFR 876.5090 · Class 1
Overview
| Product Code | FBM |
|---|---|
| Device Name | Cannula And Trocar, Suprapubic, Non-Disposable |
| Regulation | 21 CFR 876.5090 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Snowden-Pencer | Mar 12, 1996 | SESE |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Core Dynamics, Inc. | Jan 11, 1994 | SESE |
| K911813 | ENTREE CANNULA | Core Dynamics, Inc. | Jul 19, 1991 | SESE |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900964 | CANNULA AND TROCAR, 11MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900955 | GS-4000 REDUCER SLEEVE, 11MM TO 5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
Top Applicants
- Solos Endoscopy, Inc. — 6 clearances
- Core Dynamics, Inc. — 2 clearances
- Snowden-Pencer — 1 clearance
