E-Z-Em Vacuum Aspiration Syringe
FDA 510(k) K895012 · E-Z-Em, Inc.
510(k) numberK895012
Submission
- Device name
- E-Z-Em Vacuum Aspiration Syringe
- Applicant
- E-Z-Em, Inc.
Westbury, NY, US - Received
- August 8, 1989
- Decision date
- December 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
Questions and answers
When was E-Z-Em Vacuum Aspiration Syringe cleared by the FDA?
E-Z-Em Vacuum Aspiration Syringe (K895012) received a 510(k) decision of Substantially Equivalent on December 27, 1989, 141 days after the submission was received.
What is the product code of K895012?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.