Intradermal Adapter
FDA 510(k) K151777 · West Pharmaceutical Services, Inc.
510(k) numberK151777
Submission
- Device name
- Intradermal Adapter
- Applicant
- West Pharmaceutical Services, Inc.
Exton, PA, US - Received
- July 1, 2015
- Decision date
- September 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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| K240940 | Vial2Bag Advanced® 20mm Admixture DeviceLHI · Special | 05/03/2024SE |
| K163511 | NovaGuard SA Pro Safety SystemMEG · Special | 02/02/2017SE |
| K141464 | Novaguard S a Safety SystemMEG · Traditional | 09/10/2014SE |
| K123588 | Intradermal AdapterFMF · Traditional | 02/19/2013SE |
| K082908 | Novaguard, Model 3611001FMI · Abbreviated | 04/24/2009SE |
| K041691 | Clip 'N'Ject Reconstitution System (Clip 'N'JectLHI · Traditional | 08/05/2004SE |
Questions and answers
When was Intradermal Adapter cleared by the FDA?
Intradermal Adapter (K151777) received a 510(k) decision of Substantially Equivalent on September 29, 2015, 90 days after the submission was received.
What is the product code of K151777?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.