HOLDER, NEEDLE
FDA 510(k) clearance K890167 · decided 1989-02-03
Clearance details
- K-number
- K890167
- Device name
- HOLDER, NEEDLE
- Applicant
- Dhason Brothers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-09
- Decision date
- 1989-02-03
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HXK
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hyattsville, MD, 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.
| Record | Firm | Date |
|---|---|---|
| MICRINS NEEDLE HOLDER (K872989) | Micrins Surgical, Inc. | 1987-08-21 |
| FISCHER WIRE/PIN CLAMP (K860018) | Buckman Co., Inc. | 1986-02-07 |
| ACE FISCHER EXTERNAL FIXATION DEVICE (K801594) | Ace Orthopedic Manufacturing Co. | 1980-09-09 |
| CONVERSE-GILLIES NEEDLE HOLDER (K772388) | Edward Weck, Inc. | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.