510(k) K843282
- Device
- UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC
- Applicant
- RUSH HAMPTON INDUSTRIES
- 510(k) number
- K843282
- Product code
- BWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-22
- Date received
- 1984-08-20
- Regulation
- 874.4680
- Classification name
- Forceps, Biopsy, Bronchoscope (non-rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN E FRAZIER
- Address
- P.O. Box 5500 Sanford FL US 32772 32772
FDA Registration Numbers#
- 3007738736
- 3004962788
- 3005099803
- 3007695959
- 1056129
- 3008252486
- 1061927
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025-09-26 |
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | Boston Scientific Corp | 2012-05-16 |
| K102336 | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | Boston Scientific Corporation | 2011-01-24 |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Ballard Medical Products | 2002-10-11 |
| K930419 | WILTEK BIOPSY FORCEPS | Wiltek Medical, Inc. | 1993-06-01 |
Legacy Summary#
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FDA Review#
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