HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
FDA 510(k) clearance K881957 · decided 1988-05-20
Clearance details
- K-number
- K881957
- Device name
- HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
- Applicant
- N-S Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1988-05-10
- Decision date
- 1988-05-20
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, recall (Z-2021-2010) | Medical Device Technologies, Inc. | 2010-07-13 |