AUTO SUTURE* ABBI* SYSTEM
Device Facts
| Record ID | K963825 |
|---|---|
| Device Name | AUTO SUTURE* ABBI* SYSTEM |
| Applicant | United States Surgical, A Division of Tyco Healthc |
| Product Code | KNW · Gastroenterology, Urology |
| Decision Date | Dec 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
Intended Use
Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.
Device Story
Manual surgical biopsy device; used for obtaining breast tissue samples; operates under imaging control; intended for diagnostic purposes only; not for therapeutic excision; used by clinicians in surgical or clinical settings.
Clinical Evidence
No clinical data provided; performance equivalence established via comparison of intended use and functional capability to predicate device.
Technological Characteristics
Manual surgical instrument; materials compliant with ISO Standard #10993-1.
Indications for Use
Indicated for obtaining soft tissue samples from breast tissue for diagnostic purposes under imaging control.
Regulatory Classification
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Predicate Devices
- Bard® Biopsy® Instrument Biopsy-Cut® Needle (K871390)
Related Devices
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- K972328 — PERCUTANEOUS BREAST BIOPSY (PBB) · Urothealth System, Inc. · Jul 7, 1998
- K992813 — 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT · Ethicon Endo-Surgery, Inc. · Nov 18, 1999
- K020047 — RUBICOR BREAST BIOPSY DEVICE · Rubicor Medical, Inc. · Apr 5, 2002
- K012004 — EASY GUIDE ELECTROSURGICAL ACCESS DEVICE · Senorx, Inc. · Sep 25, 2001
