FIELD-LEE BRAIN BIOPSY NEEDLE
FDA 510(k) clearance K801760 · decided 1980-09-09
Clearance details
- K-number
- K801760
- Device name
- FIELD-LEE BRAIN BIOPSY NEEDLE
- Applicant
- American V. Mueller
- Decision
- Substantially Equivalent
- Date received
- 1980-07-28
- Decision date
- 1980-09-09
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- HAO
- Device class
- 1
- Regulation number
- 882.4535
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| Matreneu Percutaneous Balloon Compression Kit (K220920) | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| MULLAN GANGLION MICROCOMPRESSION SET (K940973) | Cook, Inc. | 1995-09-29 |
| RIB RESECTOR (K951492) | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115) | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| AUTO SUTURE SPINAL DISSECTOR (K942971) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL CURETTE (K942967) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL ELEVATOR (K942970) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL OSTEOTOME (K942968) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| AUTO SUTURE SPINAL NERVE HOOK (K942969) | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| SILICONE BRAIN SPATULA SET (K923723) | Redmond Neurosurgical, Inc. | 1992-08-12 |
| BONE PAD REMOVER (K910225) | Acra Cut, Inc. | 1991-02-12 |
| DURAL DISSECTORS (K910226) | Acra Cut, Inc. | 1991-02-12 |
Recalls involving this device
No recalls on record reference this clearance.