Monoscopy(Tm) Brand, Endobag
FDA 510(k) K913762 · Dexide, Inc.
510(k) numberK913762
Submission
- Device name
- Monoscopy(Tm) Brand, Endobag
- Applicant
- Dexide, Inc.
Fort Worth, TX, US - Received
- August 22, 1991
- Decision date
- October 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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
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|---|---|---|
| K991814 | Multachoice InstrumentsGEI · Special | 06/23/1999SE |
| K990379 | Modification to Multaport Cannula, Reducer and AccessoriesGCJ · Special | 03/04/1999SE |
| K981940 | Multapump Disposable Pump Head and AccessoriesGCJ · Traditional | 09/25/1998SE |
| K981941 | Multaport Cannula Reducer and AccessoriesGCJ · Traditional | 07/29/1998SE |
| K953611 | Dexide Endo-Lube KitGCJ · Traditional | 09/15/1995SE |
| K944509 | Dexide Insufflation Tubing with FilterHIF · Traditional | 02/07/1995SE |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | 03/23/1993SESK |
| K923845 | Dexide Laparoscopic AccessoriesGEI · Traditional | 11/25/1992SE |
| K921709 | Endobag, ModificationGCJ · Traditional | 07/14/1992SE |
| K912637 | Laparoscopic Electrosurgical Cannula W/RetractableGEI · Traditional | 10/04/1991SE |
Questions and answers
When was Monoscopy(Tm) Brand, Endobag cleared by the FDA?
Monoscopy(Tm) Brand, Endobag (K913762) received a 510(k) decision of Substantially Equivalent on October 28, 1991, 67 days after the submission was received.
What is the product code of K913762?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.