FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER BUBBLE STAND
K Number: K813487
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
9
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CATHETER BUBBLE STAND
- K Number
- K813487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Accurate Surgical Instruments Co.
- Date Received
- December 1, 1981
- Decision Date
- December 31, 1981
- Product Code
- FKX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKX), ordered by most recent decision date.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fresenius Liberty Select Cycler
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Lilliput APD System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CloudCath Peritoneal Dialysis Drain Set Monitoring System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Accurate Surgical Instruments Co.
| K Number | Device Name | ||
|---|---|---|---|
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Dec 15, 1995 | Substantially Equivalent |
| K920515 | INSERTION | May 4, 1992 | Substantially Equivalent |
| K910786 | TROCAR (FALLER STYLET) | Sep 19, 1991 | Substantially Equivalent |
| K910785 | TITANIUM CATHETER EXTENDER | Aug 22, 1991 | Substantially Equivalent |
| K910787 | TITANIUM CONNECTOR (2 PART) | Aug 15, 1991 | Substantially Equivalent |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Jun 19, 1986 | Substantially Equivalent |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Jul 26, 1985 | Substantially Equivalent |
| K813488 | CATHETER REGULAR | Dec 31, 1981 | Substantially Equivalent |