Reusable Bronchial Biopsy Forceps
FDA 510(k) K022398 · Ballard Medical Products
510(k) numberK022398
Submission
- Device name
- Reusable Bronchial Biopsy Forceps
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- July 23, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWH – Forceps, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code BWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | Boston Scientific Corporation | 09/26/2025SE |
| K121186 | Radial Jaw 4 Pulmonary Biopsy ForcepsBWH · Special | Boston Scientific Corp | 05/16/2012SE |
| K102336 | Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard…BWH · Traditional | Boston Scientific Corporation | 01/24/2011SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | Wiltek Medical, Inc. | 06/01/1993SE |
| K843282 | Universal by Rush-Hampton ArthroscopicBWH · Traditional | Rush Hampton Industries | 10/22/1984SE |
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| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | 03/11/1998SE |
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| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | 07/05/1995SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Reusable Bronchial Biopsy Forceps cleared by the FDA?
Reusable Bronchial Biopsy Forceps (K022398) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 80 days after the submission was received.
What is the product code of K022398?
The FDA product code is BWH – Forceps, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.