Remington Medical Centrefire 22 Biopsy Instrument
FDA 510(k) K130282 · Remington Medical, Inc.
510(k) numberK130282
Submission
- Device name
- Remington Medical Centrefire 22 Biopsy Instrument
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- February 5, 2013
- Decision date
- May 13, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
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| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
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Questions and answers
When was Remington Medical Centrefire 22 Biopsy Instrument cleared by the FDA?
Remington Medical Centrefire 22 Biopsy Instrument (K130282) received a 510(k) decision of Substantially Equivalent on May 13, 2013, 97 days after the submission was received.
What is the product code of K130282?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.