FDA product code NLU: Forceps, Biopsy, Electric, Reprocessed
NLU is the FDA product code for forceps, biopsy, electric, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under NLU, from 4 different applicants. The average 510(k) review took 78 days (median 63). FDA has posted 1 recall for NLU devices.
Definition
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 included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Electric, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NLU clearance
Top NLU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 1 | 2005-07-20 |
| Clearmedical, Inc. | 1 | 2003-11-20 |
| Surgical Instruments Service and Savings, Inc. | 1 | 2002-12-19 |
| Vanguard Medical Concepts, Inc. | 1 | 2001-09-27 |
Most recent NLU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050136 | Sterilmed, Inc. | REPROCESSED HOT BIOPSY FORCEPS | 2005-07-20 | 180 |
| K033593 | Clearmedical, Inc. | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | 2003-11-20 | 7 |
| K024011 | Surgical Instruments Service and Savings, Inc. | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | 2002-12-19 | 15 |
| K011800 | Vanguard Medical Concepts, Inc. | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | 2001-09-27 | 111 |
Recalls for NLU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-08.
Frequently asked questions
What is FDA product code NLU?
NLU is the FDA product code for forceps, biopsy, electric, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is NLU?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLU?
Across 4 cleared submissions the average was 78 days from receipt to decision (median 63).
Which companies have the most NLU clearances?
Sterilmed, Inc. (1); Clearmedical, Inc. (1); Surgical Instruments Service and Savings, Inc. (1); Vanguard Medical Concepts, Inc. (1).
Have NLU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code NLU
- Run a recall and safety report across every NLU manufacturer
- Watch product code NLU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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