Biopsy Adapter H4222W
FDA 510(k) K861050 · General Electric Co.
510(k) numberK861050
Submission
- Device name
- Biopsy Adapter H4222W
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- March 19, 1986
- Decision date
- April 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDF – Guide, Needle, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K935538 | Bauer Temno Coaxial NeedleGDF · Traditional | Bauer Medical, Inc. | 02/22/1994SE |
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| K923840 | Needle-GrabberGDF · Traditional | Guardian Angel Products, Inc. | 07/13/1993SE |
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Questions and answers
When was Biopsy Adapter H4222W cleared by the FDA?
Biopsy Adapter H4222W (K861050) received a 510(k) decision of Substantially Equivalent on April 2, 1986, 14 days after the submission was received.
What is the product code of K861050?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.