Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
FDA 510(k) K010789 · A & A Medical, Inc.
510(k) numberK010789
Submission
- Device name
- Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- March 15, 2001
- Decision date
- April 27, 2001
- 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).
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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 |
|---|---|---|
| K013491 | HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948LKF · Traditional | 11/19/2001SE |
| K013437 | SF SH Catheter, Model R65-945LKF · Traditional | 11/19/2001SE |
| K003949 | Tacker, Model R65-933OCW · Traditional | 07/25/2001SE |
| K011512 | Mmodification to LaminariaHDY · Traditional | 07/09/2001SE |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1HET · Traditional | 05/16/2001SE |
| K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450LKF · Traditional | 02/01/2001SE |
| K000027 | Insufflation Needle, Model R65-933HIF · Traditional | 04/03/2000SE |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823GCJ · Traditional | 02/03/2000SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | 05/11/1998SE |
| K974138 | Rocket ElectrodeHGI · Traditional | 01/30/1998SE |
Questions and answers
When was Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 cleared by the FDA?
Cannula, Surgical General & Plastic Surgery, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 (K010789) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 43 days after the submission was received.
What is the product code of K010789?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.