Mitek Suture Retrograder
FDA 510(k) K970360 · Mitek Products
510(k) numberK970360
Submission
- Device name
- Mitek Suture Retrograder
- Applicant
- Mitek Products
Westwood, MA, US - Received
- January 31, 1997
- Decision date
- March 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWQ – Passer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923381 | Soft Tissue ExpanderHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K920621 | Acufex Passing Pins and Surgical WireHWQ · Traditional | Acufex Microsurgical, Inc. | 05/05/1993SE |
| K885311 | Meniscus Mender II LoopHWQ · Traditional | Instrument Makar, Inc. | 02/09/1989SE |
| K843592 | Vico Micro Surgical InstrumentsHWQ · Traditional | Visitec Co. | 10/05/1984SE |
| K841623 | Slotted Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841622 | Soft-Tissue InstrumentHWQ · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | Dow Corning Corp. Healthcare Industries Materials | 07/10/1981SE |
| K791960 | Roth-Kennedy PasserHWQ · Traditional | 3M Company | 10/04/1979SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K013572 | Mitek Biocryl Interference ScrewsHWC · Special | 03/14/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | 02/06/2002SE |
| K002639 | Bioknotless AnchorGAM · Traditional | 05/11/2001SE |
| K010633 | Rigidfix Soft Tissue Acl Crosspin SystemHWC · Traditional | 05/09/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | 02/15/2001SE |
| K003076 | Mitek CufftackMAI · Special | 10/27/2000SE |
| K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemGEI · Special | 08/31/2000SE |
| K002402 | Vapr TC Electrode for Use with Vapr II Electrosurgical SystemHRX · Special | 08/31/2000SE |
| K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemGEI · Special | 04/19/2000SE |
| K993575 | Resolve QuickanchorDZL · Traditional | 12/29/1999SE |
Questions and answers
When was Mitek Suture Retrograder cleared by the FDA?
Mitek Suture Retrograder (K970360) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 38 days after the submission was received.
What is the product code of K970360?
The FDA product code is HWQ – Passer, a Class I (low risk) device regulated under 21 CFR 888.4540.