510(k) K011800
- Device
- VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
- Applicant
- VANGUARD MEDICAL CONCEPTS, INC.
- 510(k) number
- K011800
- Product code
- NLU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-27
- Date received
- 2001-06-08
- Regulation
- 876.4300
- Classification name
- Forceps, Biopsy, Electric, Reprocessed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MIKE SAMMON
- Address
- 5307 Great Oak Dr. Lakeland FL US 33815 33815
FDA Registration Numbers#
- 3032391
- 1061124
- 2011171
- 1018470
- 3011024991
Source Documents#
Other 510(k) Records For Product Code NLU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | Sterilmed, Inc. | 2005-07-20 |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | Clearmedical, Inc. | 2003-11-20 |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | Surgical Instruments Service and Savings, Inc. | 2002-12-19 |
Legacy Summary#
summary
FDA Review#
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