Absorbalbe Anchor
FDA 510(k) K944051 · Mitek Surgical Products, Inc.
510(k) numberK944051
Submission
- Device name
- Absorbalbe Anchor
- Applicant
- Mitek Surgical Products, Inc.
Westwood, MA, US - Received
- August 19, 1994
- Decision date
- August 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MNV – Strip, Dialysate Ph Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MNV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101750 | RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips…MNV · Traditional | Reprocessing Products Corp | 01/07/2011SE |
| K031267 | Sterichek Bicarb PH Reagent StripsMNV · Traditional | Environmental Test Systems, Inc. | 12/23/2003SE |
| K936311 | Mitek Mini AnchorMNV · Traditional | Mitek Surgical Products, Inc. | 10/31/1995SN |
| K941599 | Mitek Absorbable AnchorMNV · Traditional | Mitek Surgical Products, Inc. | 10/24/1995SN |
| K945491 | Serim(Tm) Bicarb PH Reagent StripsMNV · Traditional | Serim Research Corp. | 02/01/1995SE |
More from Serim Research Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953560 | Mitek Threaded Anchor (Fastin)MBI · Traditional | 01/31/1996SN |
| K953877 | Mitek Gii AnchorMBI · Traditional | 12/29/1995SE |
| K936311 | Mitek Mini AnchorMNV · Traditional | 10/31/1995SN |
| K941599 | Mitek Absorbable AnchorMNV · Traditional | 10/24/1995SN |
| K950070 | Mitek Toggle Anchor(Tm)JDR · Traditional | 05/22/1995SE |
| K944936 | Mitek G III Anchor, Mitek LS AnchorJDR · Traditional | 03/24/1995SE |
| K945203 | Mitek Thraded Anchor (Mta)JDR · Traditional | 03/06/1995SE |
| K934366 | Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue WasherHWC · Traditional | 10/07/1994SN |
| K931782 | Mitek Giii AnchorJDR · Traditional | 07/22/1994SN |
| K931253 | Quickanchor IIJDR · Traditional | 06/16/1994SE |
Questions and answers
When was Absorbalbe Anchor cleared by the FDA?
Absorbalbe Anchor (K944051) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 348 days after the submission was received.
What is the product code of K944051?
The FDA product code is MNV – Strip, Dialysate Ph Indicator, a Class II (moderate risk) device regulated under 21 CFR 876.5820.