Galileo Disposable Endoscopes
FDA 510(k) K981928 · Galileo Electro-Optics Corp.
510(k) numberK981928
Submission
- Device name
- Galileo Disposable Endoscopes
- Applicant
- Galileo Electro-Optics Corp.
North Attleboro, MA, US - Received
- June 2, 1998
- Decision date
- August 6, 1998
- 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).
Other 510(k)s with product code GCJ
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|---|---|---|---|
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| 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 |
|---|---|---|
| K962256 | Galileo Hysteroscopes and LaparoscopesHIH · Traditional | 12/06/1996SE |
| K962116 | Galileo EndoscopesEOB · Traditional | 11/27/1996SE |
| K934649 | Galileo EndoscopesFBO · Traditional | 10/13/1994SE |
| K934707 | Galileo ArthroscopesHRX · Traditional | 10/07/1994SE |
| K936280 | Galileo ArthroscopesHRX · Traditional | 07/12/1994SE |
| K936279 | Galileo EndoscopesGCJ · Traditional | 05/16/1994SE |
Questions and answers
When was Galileo Disposable Endoscopes cleared by the FDA?
Galileo Disposable Endoscopes (K981928) received a 510(k) decision of Substantially Equivalent on August 6, 1998, 65 days after the submission was received.
What is the product code of K981928?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.