Novatome, Model: SU101-50
FDA 510(k) K072051 · Scholten Surgical Instruments, Inc.
510(k) numberK072051
Submission
- Device name
- Novatome, Model: SU101-50
- Applicant
- Scholten Surgical Instruments, Inc.
Lodi, CA, US - Received
- July 26, 2007
- Decision date
- October 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWZ – Device, Biopsy, Endomyocardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4075
- Specialty
- Cardiovascular
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| K010473 | Sparrowhawk DisposableDWZ · Traditional | Atc Technologies, Inc. | 06/06/2001SE |
| K000409 | Modification to T-Rex Biopsy ForcepsDWZ · Special | Boston Scientific Corp | 02/28/2000SE |
| K991486 | Ultra-CbxDWZ · Traditional | Medcanica, Inc. | 11/05/1999SE |
| K974175 | Heartport Endoaortic Clamp CatheterDWZ · Traditional | Heartport, Inc. | 12/16/1997SE |
| K973818 | T-Rex Biopsy ForcepsDWZ · Traditional | Boston Scientific Corp | 12/16/1997SE |
| K951447 | Dynabite Cardiovascular Biopsy ForcepsDWZ · Traditional | Portlyn Corp. | 07/27/1995SE |
| K933235 | Cordis Bipal 7 /Biopsy & Bipal Biopsy Forceps, ModifDWZ · Traditional | Cordis Corp. | 01/06/1994SE |
| K932788 | Cordis Bipal 7 Biopsy Forceps with a Inline HandleDWZ · Traditional | Cordis Corp. | 09/01/1993SE |
More from Cordis Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K900405 | Scholten FrameJEB · Traditional | 03/01/1990SE |
| K852331 | Sys, Angiographic, Single-Or Bi-Plane RadiographicIZI · Traditional | 08/01/1986SE |
| K852119 | Temporary Pacemaker Ground WireDTB · Traditional | 09/15/1985SE |
| K852332 | Table Accessories, Operating RoomBWN · Traditional | 07/02/1985SE |
| K852120 | Forceps, Biopsy(Non Rigid)GEN · Traditional | 07/02/1985SE |
| K852330 | Retractor, SurgicalGAD · Traditional | 06/27/1985SE |
| K852329 | Stand, Operating RoomFOX · Traditional | 06/14/1985SE |
Questions and answers
When was Novatome, Model: SU101-50 cleared by the FDA?
Novatome, Model: SU101-50 (K072051) received a 510(k) decision of Substantially Equivalent on October 3, 2007, 69 days after the submission was received.
What is the product code of K072051?
The FDA product code is DWZ – Device, Biopsy, Endomyocardial, a Class II (moderate risk) device regulated under 21 CFR 870.4075.