CDSCO UID IMP/MD/2022/000425_884fd18f01288e2fc85246752a977373_9d14bff9f667779c90e652dd48e242e1
Biopsy Needles
Becton Dickinson India Private Limited·Device Class Class B·India CDSCO·Brand: EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System
Registration details
- UID
- IMP/MD/2022/000425_884fd18f01288e2fc85246752a977373_9d14bff9f667779c90e652dd48e242e1
- Device class
- Class B
- Brand name
- EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System
- License holder
- Becton Dickinson India Private Limited
- Approving authority
- CDSCO
- Product information
- The EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. • It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System), the EnCor Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures
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About this record
Biopsy Needles is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000425_884fd18f01288e2fc85246752a977373_9d14bff9f667779c90e652dd48e242e1. This device is marketed under the brand name EnCor Ultra® Breast Biopsy System & EnCor Enspire® Breast Biopsy System. The license holder is Becton Dickinson India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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