Modification to Confluent Surgical Micromyst Applicator and Air Pump
FDA 510(k) K070814 · Confluent Surgical,Inc
510(k) numberK070814
Submission
- Device name
- Modification to Confluent Surgical Micromyst Applicator and Air Pump
- Applicant
- Confluent Surgical,Inc
Waltham, MA, US - Received
- March 26, 2007
- Decision date
- May 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K091315 | Covidien Extended Tip ApplicatorFMF · Special | 06/05/2009SE |
| K072790 | Confluent Surgical Extended Tip Applicator, Model 70-2008-008FMF · Traditional | 01/11/2008SE |
| K061183 | Confluent Surgical Dual Liquid Applicator, Model 70-2005-093FMF · Special | 06/01/2006SE |
| K050998 | Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-A-6063FMF · Traditional | 06/15/2005SE |
| K042588 | Confluent Surgical Dual Liquid Applicator, Model 70-2005093FMF · Traditional | 12/09/2004SE |
Questions and answers
When was Modification to Confluent Surgical Micromyst Applicator and Air Pump cleared by the FDA?
Modification to Confluent Surgical Micromyst Applicator and Air Pump (K070814) received a 510(k) decision of Substantially Equivalent on May 30, 2007, 65 days after the submission was received.
What is the product code of K070814?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.