Reprocessed Single Use Devices Biopsy Forceps
FDA 510(k) K033593 · Clearmedical, Inc.
510(k) numberK033593
Submission
- Device name
- Reprocessed Single Use Devices Biopsy Forceps
- Applicant
- Clearmedical, Inc.
Bellevue, WA, US - Received
- November 13, 2003
- Decision date
- November 20, 2003
- 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 |
| K024011 | Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical…NLU · Traditional | Surgical Instruments Service and Savings, Inc. | 12/19/2002SE |
| K011800 | Vanguard Reprocessed Electric Biopsy ForcepsNLU · Traditional | Vanguard Medical Concepts, Inc. | 09/27/2001SE |
More from Vanguard Medical Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033579 | Reprocessed Multiple Clip AppliersNMJ · Traditional | 07/11/2005SE |
| K033578 | Reprocessed Reloadable Cutters, Staplers, and AppliersNLL · Traditional | 07/11/2005SE |
| K033591 | Reprocessed TrocarsKBG · Traditional | 06/03/2005SE |
| K033592 | Reprocessed Surgical Scissors and GraspersGEI · Traditional | 07/27/2004SE |
| K031416 | Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffDXQ · Traditional | 07/15/2003SE |
| K012622 | Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20NLF · Traditional | 07/03/2002SE |
| K012609 | Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25NLF · Traditional | 07/03/2002SE |
| K012600 | Clearmedical/Nellcor Oxisensor II, Adult, Model D-25/D-25LNLF · Traditional | 07/03/2002SE |
| K012621 | Clearmedical/Hentleigh Deep Vein Thrombosis (DVT) GarmentJOW · Traditional | 02/06/2002SE |
| K012616 | Clearmedical/Huntleigh Foot Garments; Models FG200/LRG (Large), FG200/STD (Standard)…JOW · Traditional | 02/06/2002SE |
Questions and answers
When was Reprocessed Single Use Devices Biopsy Forceps cleared by the FDA?
Reprocessed Single Use Devices Biopsy Forceps (K033593) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 7 days after the submission was received.
What is the product code of K033593?
The FDA product code is NLU – Forceps, Biopsy, Electric, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.4300.