Disposable Surgical Trocar with Seal
FDA 510(k) K911589 · Applied Vascular Devices, Inc.
510(k) numberK911589
Submission
- Device name
- Disposable Surgical Trocar with Seal
- Applicant
- Applied Vascular Devices, Inc.
Laguna Hills, CA, US - Received
- April 9, 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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| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| 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 |
|---|---|---|
| K911730 | Surgical Obturator with SealGCJ · Traditional | 12/23/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | 05/29/1991SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | 04/26/1991SE |
| K911181 | Intimax(Tm) Irrigation CatheterGCA · Traditional | 04/18/1991SE |
| K910493 | Avd Intimax Cholangiography CatheterFGE · Traditional | 03/28/1991SE |
| K903848 | Diagnostic Intrascular CatheterDQO · Traditional | 03/25/1991SE |
| K905738 | Operative Cholangiographic CatheterFGE · Traditional | 03/21/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | 02/27/1991SE |
| K902256 | Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional | 02/15/1991SE |
| K904379 | Surgical Trocar and CannulaHET · Traditional | 12/21/1990SE |
Questions and answers
When was Disposable Surgical Trocar with Seal cleared by the FDA?
Disposable Surgical Trocar with Seal (K911589) received a 510(k) decision of Substantially Equivalent on July 5, 1991, 87 days after the submission was received.
What is the product code of K911589?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.