Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
K170897 is the FDA 510(k) clearance record for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code PTI (Non-Coring (Huber) Needle). FDA's definition for product code PTI reads: "The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums". FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K170897.
Clearance record
- Decision date
- Received
- (221 days to decision)
- Product code
- PTI Non-Coring (Huber) Needle
- Regulation
- 21 CFR 880.5570
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- B.Braun Medical, Inc. 901 Marcon Blvd., Allentown PA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code PTI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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