510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NLUClass II

Forceps, Biopsy, Electric, Reprocessed

21 CFR 876.4300 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NLU is the FDA product code for Forceps, Biopsy, Electric, Reprocessed, a class II device type, regulated under 21 CFR 876.4300. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NLU
Device name
Forceps, Biopsy, Electric, Reprocessed
FDA 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).
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code NLU

By decision year
4 clearances under product code NLU with a decision year between 2001 and 2005, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NLU by decision year
YearClearances
20011
20021
20031
20051

Applicants with the most clearances

Product code NLU
Applicants holding the most 510(k) clearances under product code NLU
ApplicantClearances
Clearmedical, Inc.1
Sterilmed Inc1
Surgical Instruments Service and Savings, Inc.1
Stryker Sustainability Solutions1

Companies listing this code with FDA

Companies whose registered establishments list this code