Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable
FDA 510(k) K012023 · Senorx, Inc.
510(k) numberK012023
Submission
- Device name
- Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable
- Applicant
- Senorx, Inc.
Aliso Viejo, CA, US - Received
- June 28, 2001
- Decision date
- September 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K093512 | Encor Breast Biopsy SystemKNW · Traditional | 11/20/2009SE |
| K092323 | Contura Cavity Maintenance CatheterJAQ · Traditional | 08/19/2009SE |
| K082264 | Contura Lumen MarkerJAQ · Traditional | 09/12/2008SESU |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | 05/28/2008SE |
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Questions and answers
When was Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable cleared by the FDA?
Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable (K012023) received a 510(k) decision of Substantially Equivalent on September 12, 2001, 76 days after the submission was received.
What is the product code of K012023?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.