Cabot Medical Surgiflex(R) Suction-Irrigation Prob
FDA 510(k) K932626 · Cabot Medical Corp.
510(k) numberK932626
Submission
- Device name
- Cabot Medical Surgiflex(R) Suction-Irrigation Prob
- Applicant
- Cabot Medical Corp.
Langhorne, PA, US - Received
- June 1, 1993
- Decision date
- June 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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).
Other 510(k)s with product code GCJ
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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 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| 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 |
|---|---|---|
| K960148 | Circon-Surgitek Classic Double Pigtail Ureteral StentFAD · Traditional | 03/25/1996SE |
| K946109 | Cabot Medical Reusable Bipolar Cutting ForcepsKNS · Traditional | 11/21/1995SE |
| K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsFBO · Traditional | 07/21/1995SE |
| K951714 | Cabot Medical-Surgitek Ultragold Plus Side-Firing Urologic Laser FiberGEX · Traditional | 07/11/1995SE |
| K941743 | Cabot Medical Niagara Fluid Management PumpHIG · Traditional | 04/19/1995SE |
| K934115 | 3000 Electronic Insufflator ModificationHIF · Traditional | 03/15/1995SE |
| K932293 | Cabot Medical Bipolar Cutting ForcepsKNS · Traditional | 07/27/1994SE |
| K930954 | The Cabot Medical Insul-Sheth Vaginal Speculum CovHIB · Traditional | 06/30/1994SE |
| K935786 | Corson and Nezhat Suction/Irrigation ProbesGCJ · Traditional | 05/19/1994SE |
| K924631 | Cabot Medical Uterine ResectoscopeHIH · Traditional | 05/16/1994SE |
Questions and answers
When was Cabot Medical Surgiflex(R) Suction-Irrigation Prob cleared by the FDA?
Cabot Medical Surgiflex(R) Suction-Irrigation Prob (K932626) received a 510(k) decision of Substantially Equivalent on June 8, 1994, 372 days after the submission was received.
What is the product code of K932626?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.