Laparoscopic Irrigation/Aspiration Handpiece
FDA 510(k) K930756 · Endo Technic Corp.
510(k) numberK930756
Submission
- Device name
- Laparoscopic Irrigation/Aspiration Handpiece
- Applicant
- Endo Technic Corp.
Atlanta, GA, US - Received
- February 12, 1993
- Decision date
- March 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K990908 | MillenniumMXF · Traditional | 05/27/1999SE |
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| K925079 | Laparoscopic Inst. (Scissors,Forceps,Needleholder)HET · Traditional | 08/24/1994SE |
| K925114 | Laparoscopic InstrumentsHFI · Traditional | 02/28/1994SE |
| K924058 | TrocarGCJ · Traditional | 03/30/1993SE |
| K914825 | 1-125 EndoseedKXK · Traditional | 03/19/1992SE |
| K910200 | LASER-35GEX · Traditional | 05/09/1991SE |
| K864976 | Soluset Calcium Demineralizing SolutionEKS · Traditional | 02/27/1987SE |
| K862129 | Set Canal Sealer PasteEKM · Traditional | 07/22/1986SE |
Questions and answers
When was Laparoscopic Irrigation/Aspiration Handpiece cleared by the FDA?
Laparoscopic Irrigation/Aspiration Handpiece (K930756) received a 510(k) decision of Substantially Equivalent on March 9, 1994, 390 days after the submission was received.
What is the product code of K930756?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.