Endoscopes, Fiber Optic Laparoscopes, (Sterilizable)
FDA 510(k) K951482 · Micro-Medical Devices, Inc.
510(k) numberK951482
Submission
- Device name
- Endoscopes, Fiber Optic Laparoscopes, (Sterilizable)
- Applicant
- Micro-Medical Devices, Inc.
Castle Pines Village, CO, US - Received
- March 30, 1995
- Decision date
- September 14, 1995
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K003695 | Microscope-Stainless Steel/Fiber Optic: .5-2.6MM Model MMD 4500 Series and 2.7-5.0MM…HRX · Traditional | 02/14/2001SE |
| K983882 | Micro Endoscope-Stainless Steel, Model MMD-1300, Micro Endoscope-Polyimide,Model MMD-1400HXR · Traditional | 03/15/1999SE |
| K963675 | The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile DrapeKKX · Traditional | 01/27/1997SE |
| K951894 | Access Expansion SystemFHO · Traditional | 06/15/1995SESK |
| K945656 | The Coupler/Drape(Tm), Video Camera Sterile DrapeKKX · Traditional | 03/28/1995SE |
| K940141 | Laparaoscopes Electronic with Sterile SheathGCJ · Traditional | 05/19/1994SE |
| K936213 | Arthroscopes and AccessoriesHRX · Traditional | 05/18/1994SE |
Questions and answers
When was Endoscopes, Fiber Optic Laparoscopes, (Sterilizable) cleared by the FDA?
Endoscopes, Fiber Optic Laparoscopes, (Sterilizable) (K951482) received a 510(k) decision of Substantially Equivalent on September 14, 1995, 168 days after the submission was received.
What is the product code of K951482?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.