FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K Number: K840752
·
Decision May 2, 1984
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
56
Review Days
69
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
- ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
- K Number
- K840752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- E-Z-Em, Inc.
- Date Received
- February 23, 1984
- Decision Date
- May 2, 1984
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by E-Z-Em, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | Jun 13, 2007 | Substantially Equivalent |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | Apr 13, 2007 | Substantially Equivalent |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | Nov 2, 2006 | Substantially Equivalent |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | Dec 27, 2005 | Substantially Equivalent |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | Jul 16, 2004 | Substantially Equivalent |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | Jun 19, 2003 | Substantially Equivalent |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | Apr 16, 2003 | Substantially Equivalent |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | Feb 19, 2002 | Substantially Equivalent |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | May 16, 2001 | Substantially Equivalent |
| K974621 | PERCUPUMP II WITH EDA | Jan 27, 1998 | Substantially Equivalent |