Universal by Rush-Hampton Arthroscopic
FDA 510(k) K843282 · Rush Hampton Industries
510(k) numberK843282
Submission
- Device name
- Universal by Rush-Hampton Arthroscopic
- Applicant
- Rush Hampton Industries
Sanford, FL, US - Received
- August 20, 1984
- Decision date
- October 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | Ballard Medical Products | 10/11/2002SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | Wiltek Medical, Inc. | 06/01/1993SE |
Questions and answers
When was Universal by Rush-Hampton Arthroscopic cleared by the FDA?
Universal by Rush-Hampton Arthroscopic (K843282) received a 510(k) decision of Substantially Equivalent on October 22, 1984, 63 days after the submission was received.
What is the product code of K843282?
The FDA product code is BWH – Forceps, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.