Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes
FDA 510(k) K972280 · Wilson Greatbatch Technologies, Inc.
510(k) numberK972280
Submission
- Device name
- Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes
- Applicant
- Wilson Greatbatch Technologies, Inc.
Clarence, NY, US - Received
- June 18, 1997
- Decision date
- December 11, 1997
- 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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| 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 |
|---|---|---|
| K971374 | Greatbatch Scientific MR Compatible HysteroscopeHIH · Traditional | 05/13/1998SE |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | 04/30/1998SE |
| K971781 | Greatbatch Scientific MR Compatible Arthroscopes and Small Joint ArthroscopesHRX · Traditional | 11/21/1997SE |
| K970619 | Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope HandleCCW · Traditional | 11/19/1997SE |
| K971375 | Greatbatch Scientific MR Compatible SinuscopeEOB · Traditional | 10/31/1997SE |
| K954649 | WGL Endoscopic Grasper W/Detachable StrapGCJ · Traditional | 12/22/1995SE |
| K950063 | WGL Endoscopic Grasper*GCJ · Traditional | 01/27/1995SE |
| K942168 | WGL Endoscopic GrasperGCJ · Traditional | 12/13/1994SE |
Questions and answers
When was Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes cleared by the FDA?
Greatbatch Scientific MR Compatible Laparoscopes and Operating Laparoscopes (K972280) received a 510(k) decision of Substantially Equivalent on December 11, 1997, 176 days after the submission was received.
What is the product code of K972280?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.