Amcath Disposable Micro Scissors
FDA 510(k) K912605 · Intl. Medical, Inc.
510(k) numberK912605
Submission
- Device name
- Amcath Disposable Micro Scissors
- Applicant
- Intl. Medical, Inc.
Danielson, CT, US - Received
- June 12, 1991
- Decision date
- July 11, 1991
- 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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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
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| K940370 | American Catheter E.R.C.P. CannulaFGE · Traditional | 08/17/1994SE |
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| K930410 | Durham; Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
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| K923200 | Amcath Disposable Cytology BrushFDX · Traditional | 12/07/1992SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | 01/10/1992SE |
| K912927 | Amcath Disposable Trocar and Trocar SleeveGCJ · Traditional | 09/19/1991SE |
Questions and answers
When was Amcath Disposable Micro Scissors cleared by the FDA?
Amcath Disposable Micro Scissors (K912605) received a 510(k) decision of Substantially Equivalent on July 11, 1991, 29 days after the submission was received.
What is the product code of K912605?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.