Shieldedtrocar/Cannula System, Model 101-005-101
FDA 510(k) K991382 · Genicon, LC
510(k) numberK991382
Submission
- Device name
- Shieldedtrocar/Cannula System, Model 101-005-101
- Applicant
- Genicon, LC
Orlando, FL, US - Received
- April 21, 1999
- Decision date
- July 15, 1999
- 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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| 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 |
|---|---|---|
| K030174 | Genicon LaparoscopesGCJ · Traditional | 06/19/2003SE |
| K030269 | Genicon Clip ApplierFZP · Traditional | 03/20/2003SE |
| K002542 | Reusable CannulaGCJ · Traditional | 10/23/2000SE |
| K993625 | Insufflation Needle- 120MM, Model 900-200HIF · Traditional | 06/20/2000SE |
| K982472 | Genicon TrocarGEA · Traditional | 02/04/1999SE |
Questions and answers
When was Shieldedtrocar/Cannula System, Model 101-005-101 cleared by the FDA?
Shieldedtrocar/Cannula System, Model 101-005-101 (K991382) received a 510(k) decision of Substantially Equivalent on July 15, 1999, 85 days after the submission was received.
What is the product code of K991382?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.