DR Safety Syringe, Sterile Hypodermic needle for Single use
FDA 510(k) clearance K212226 · decided 2021-09-29
Clearance details
- K-number
- K212226
- Device name
- DR Safety Syringe, Sterile Hypodermic needle for Single use
- Applicant
- Zhuhai DR Medical Instruments Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-16
- Decision date
- 2021-09-29
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Zhuhai, CN
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zhuhai DR Medical Instruments 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.
Recalls involving this device
No recalls on record reference this clearance.