Monoscopy Brand, 5 MM Locking Trocar Sleeve
FDA 510(k) K896205 · Dexide, Inc.
510(k) numberK896205
Submission
- Device name
- Monoscopy Brand, 5 MM Locking Trocar Sleeve
- Applicant
- Dexide, Inc.
Fort Worth, TX, US - Received
- October 26, 1989
- Decision date
- March 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCI – Laryngoscope, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| 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 |
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Questions and answers
When was Monoscopy Brand, 5 MM Locking Trocar Sleeve cleared by the FDA?
Monoscopy Brand, 5 MM Locking Trocar Sleeve (K896205) received a 510(k) decision of Substantially Equivalent on March 22, 1990, 147 days after the submission was received.
What is the product code of K896205?
The FDA product code is GCI – Laryngoscope, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.