Myocard Biopsy Forcep
FDA 510(k) K881412 · Fehling Medizintechnik GmbH
510(k) numberK881412
Submission
- Device name
- Myocard Biopsy Forcep
- Applicant
- Fehling Medizintechnik GmbH
West Germany, DE - Received
- April 4, 1988
- Decision date
- September 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWZ – Device, Biopsy, Endomyocardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4075
- Specialty
- Cardiovascular
Other 510(k)s with product code DWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252722 | Biopsy ForcepsDWZ · Special | Fehling Instruments GmbH | 09/30/2025SE |
| K170726 | Biopsy ForcepsDWZ · Traditional | Fehling Instruments GmbH & Co. KG | 06/02/2017SE |
| K072051 | Novatome, Model: SU101-50DWZ · Traditional | Scholten Surgical Instruments, Inc. | 10/03/2007SE |
| 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 |
Questions and answers
When was Myocard Biopsy Forcep cleared by the FDA?
Myocard Biopsy Forcep (K881412) received a 510(k) decision of Substantially Equivalent on September 8, 1988, 157 days after the submission was received.
What is the product code of K881412?
The FDA product code is DWZ – Device, Biopsy, Endomyocardial, a Class II (moderate risk) device regulated under 21 CFR 870.4075.