Irrigation Pump and Tubing Set
FDA 510(k) K924611 · Marlo Surgical Technology
510(k) numberK924611
Submission
- Device name
- Irrigation Pump and Tubing Set
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- September 11, 1992
- Decision date
- June 30, 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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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960810 | Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X…HET · Traditional | 10/21/1996SE |
| K962273 | Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMFD · Traditional | 07/31/1996SE |
| K932832 | Primus Insulated ForcepsHET · Traditional | 02/25/1994SE |
| K932634 | Nu-Tip(Tm) Forceps:Graspers/Dissectors/SuturesHET · Traditional | 02/25/1994SE |
| K920611 | Marlow Laparoscopic Grasping ForcepGCJ · Traditional | 04/20/1993SE |
| K914153 | Ott Insufflator Filter Plus/Tubing SetHIF · Traditional | 04/02/1992SE |
| K914869 | Marlow Laparoscopic ScissorsGCJ · Traditional | 01/15/1992SE |
| K913954 | Marlow/Reddick Laparoscopic Needle HoldersGCJ · Traditional | 12/18/1991SE |
| K914872 | Marlow Suction/Irrigation ProbesGSJ · Traditional | 11/19/1991SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | 10/23/1991SE |
Questions and answers
When was Irrigation Pump and Tubing Set cleared by the FDA?
Irrigation Pump and Tubing Set (K924611) received a 510(k) decision of Substantially Equivalent on June 30, 1994, 657 days after the submission was received.
What is the product code of K924611?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.