PERCUSSION HAMMER
FDA 510(k) clearance K891571 · decided 1989-03-31
Clearance details
- K-number
- K891571
- Device name
- PERCUSSION HAMMER
- Applicant
- Sandal Surgico
- Decision
- Substantially Equivalent
- Date received
- 1989-03-20
- Decision date
- 1989-03-31
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- GWZ
- Device class
- 1
- Regulation number
- 882.1700
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sialkot, PK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sandal Surgico
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 |
|---|---|---|
| TAYLOR PERCUSSION HAMMER SS 410 OR 420 (K852716) | The Huxley Instrument Corp. | 1985-07-26 |
| 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE (K851748) | Artiberia | 1985-06-13 |
| H.R. JAKOBI SURG. INSTR. #10 34/36 (K834178) | Imm Enterprises , Ltd. | 1984-02-23 |
| CAT 10-NEUROLOGY DEVICE (K840314) | Imm Enterprises , Ltd. | 1984-02-23 |
| OP-CON SURG. INSTRUMENT #10 (K834170) | Imm Enterprises , Ltd. | 1984-02-23 |
| RICA (DIAGNOSTIC INSTRUMENTS) (K810054) | Robert I. Chien & Assoc., Inc. | 1981-01-28 |
| CONPHAR PERCUSSION HAMMER(TAYLOR) (K803148) | Conphar, Inc. | 1981-01-08 |
| CONPHAR PERCUSSION HAMMER(BUCK TYPE) (K803174) | Conphar, Inc. | 1980-12-30 |
| TAYLOR NEUROLOGICAL HAMMER (K791337) | Amdia Medical Products | 1979-08-03 |
| BUCKS NEUROLOGICAL HAMMER (K791336) | Amdia Medical Products | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.