Reich Suction/Irrigation Cannula
FDA 510(k) K911164 · Marlo Surgical Technology
510(k) numberK911164
Submission
- Device name
- Reich Suction/Irrigation Cannula
- Applicant
- Marlo Surgical Technology
Willoughby, OH, US - Received
- March 15, 1991
- Decision date
- July 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 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 |
| K924611 | Irrigation Pump and Tubing SetHET · Traditional | 06/30/1994SE |
| 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 |
Questions and answers
When was Reich Suction/Irrigation Cannula cleared by the FDA?
Reich Suction/Irrigation Cannula (K911164) received a 510(k) decision of Substantially Equivalent on July 5, 1991, 112 days after the submission was received.
What is the product code of K911164?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.