Reusable Endoscopic Scissors, Grasper-Monopolar
FDA 510(k) K926583 · T. Korossurgical Instruments Corp.
510(k) numberK926583
Submission
- Device name
- Reusable Endoscopic Scissors, Grasper-Monopolar
- Applicant
- T. Korossurgical Instruments Corp.
Moorepark, CA, US - Received
- September 18, 1992
- Decision date
- August 6, 1993
- 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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| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
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| 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 |
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| K953998 | Discetome Tissue AspiratorHRX · Traditional | 12/04/1995SE |
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| K935529 | Cervical Self-Retaining RetractorGZT · Traditional | 03/22/1994SE |
| K931262 | Reusable/Interchangeable Shaft, Endoscopic ScissorGCJ · Traditional | 08/06/1993SE |
| K926585 | Thorocoscopy Self-Retaining RetractorGAD · Traditional | 08/06/1993SE |
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Questions and answers
When was Reusable Endoscopic Scissors, Grasper-Monopolar cleared by the FDA?
Reusable Endoscopic Scissors, Grasper-Monopolar (K926583) received a 510(k) decision of Substantially Equivalent on August 6, 1993, 322 days after the submission was received.
What is the product code of K926583?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.