Vanguard Reprocessed Electric Biopsy Forceps
FDA 510(k) K011800 · Vanguard Medical Concepts, Inc.
Submission
- Device name
- Vanguard Reprocessed Electric Biopsy Forceps
- Applicant
- Vanguard Medical Concepts, Inc.
Lakeland, FL, US - Received
- June 8, 2001
- Decision date
- September 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLU – Forceps, Biopsy, Electric, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be…
Other 510(k)s with product code NLU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050136 | Reprocessed Hot Biopsy ForcepsNLU · Traditional | Sterilmed, Inc. | 07/20/2005SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | Clearmedical, Inc. | 11/20/2003SE |
| K024011 | Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical…NLU · Traditional | Surgical Instruments Service and Savings, Inc. | 12/19/2002SE |
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| K053051 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 12/22/2005SE |
| K051616 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 09/06/2005SE |
| K051180 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 07/22/2005SE |
| K051043 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/06/2005SE |
| K050763 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/01/2005SE |
| K043198 | Vanguard Reprocessed Arthroscopic WandsNUJ · Traditional | 05/27/2005SE |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional | 04/08/2005SE |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional | 03/31/2005SE |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
| K043225 | Vanguard Reprocessed Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
Questions and answers
When was Vanguard Reprocessed Electric Biopsy Forceps cleared by the FDA?
Vanguard Reprocessed Electric Biopsy Forceps (K011800) received a 510(k) decision of Substantially Equivalent on September 27, 2001, 111 days after the submission was received.
What is the product code of K011800?
The FDA product code is NLU – Forceps, Biopsy, Electric, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.4300.