Biopsy Forceps
FDA 510(k) K895098 · Annex Medical, Inc.
510(k) numberK895098
Submission
- Device name
- Biopsy Forceps
- Applicant
- Annex Medical, Inc.
Eden Prairie, MN, US - Received
- August 15, 1989
- Decision date
- October 30, 1989
- 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 |
More from Cordis Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K954377 | Forceps, Grasping, Flexible EndoscopicFFL · Traditional | 10/26/1995SE |
| K952863 | Forceps, Biopsy, Non-ElectricFCL · Traditional | 07/19/1995SE |
| K951532 | Metal Ureteral Basket Stone DislodgerFFL · Traditional | 07/19/1995SE |
| K951761 | Metel Ureteral Basket Stone DislodgerFFL · Traditional | 05/11/1995SE |
| K934636 | Annex Medical Flat Wire Stone ExtractorFFL · Traditional | 02/25/1994SE |
| K934675 | Metal Ureteral Basket Stone DislodgerFFL · Traditional | 01/07/1994SE |
| K934598 | Grasping Forceps or Retrieval ForcepsFGO · Traditional | 01/07/1994SE |
| K925267 | Grasping Forceps or Retrieval ForcepsGCJ · Traditional | 02/10/1993SE |
| K925559 | Biliary Stone DislodgerLQR · Traditional | 12/17/1992SE |
| K921401 | Biopsy ForcepsDWZ · Traditional | 10/21/1992SE |
Questions and answers
When was Biopsy Forceps cleared by the FDA?
Biopsy Forceps (K895098) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 76 days after the submission was received.
What is the product code of K895098?
The FDA product code is DWZ – Device, Biopsy, Endomyocardial, a Class II (moderate risk) device regulated under 21 CFR 870.4075.