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

Staple, Implantable, Reprocessed

21 CFR 878.4750 / General, Plastic Surgery
FDA source (opens on fda.gov)

NLL is the FDA product code for Staple, Implantable, Reprocessed, a class II device type, regulated under 21 CFR 878.4750. FDA's definition for this code reads: "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)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NLL
Device name
Staple, Implantable, Reprocessed
FDA definition
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 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code NLL

By decision year
3 clearances under product code NLL with a decision year between 2005 and 2007, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NLL by decision year
YearClearances
20051
20072

Applicants with the most clearances

Product code NLL
Applicants holding the most 510(k) clearances under product code NLL
ApplicantClearances
Sterilmed Inc2
Clearmedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLL.