BIOPSY ADAPTER #H4221BG
FDA 510(k) clearance K864551 · decided 1986-12-23
Clearance details
- K-number
- K864551
- Device name
- BIOPSY ADAPTER #H4221BG
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-19
- Decision date
- 1986-12-23
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- GDF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch General Electric Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173) | Needle Tech Products, Inc. | 2003-07-23 |
| GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311) | Global Medical Products, Ltd. | 1995-05-26 |
| SURGICAL INSTRUMENT GUIDE (K950007) | United States Surgical, A Division of Tyco Healthc | 1995-03-15 |
| BREAST LESION LOCALIZATION NEEDLE (K945124) | Promex, Inc. | 1994-11-22 |
| BREAST LESION LOCALIZATION NEEDLE (K944942) | Promedical , Ltd. | 1994-11-04 |
| BAUER TEMNO COAXIAL NEEDLE (K935538) | Bauer Medical, Inc. | 1994-02-22 |
| LOCALIZATION WIRE OR MARKER - SURGICAL (K935457) | Bip USA, Inc. | 1994-02-17 |
| NEEDLE-GRABBER (K923840) | Guardian Angel Products, Inc. | 1993-07-13 |
| THE ELEVENTH FINGER (K923835) | Guardian Angel Products, Inc. | 1993-07-09 |
| HORIZONTAL NEEDLE GUIDE ATTACHMENT (K925875) | Bip USA, Inc. | 1993-04-06 |
| BREAST LESION LOCALIZATION NEEDLE (K924270) | Core Medical, Inc. | 1992-09-23 |
| MICROGUIDE LESION MARKING SYSTEM (K923120) | Angiodynamics, Div. E-Z-Em, Inc. | 1992-09-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |