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NLQUnclassified

Single-Use Reprocessed Ultrasonic Surgical Instruments

Unknown

NLQ is the FDA product code for Single-Use Reprocessed Ultrasonic Surgical Instruments. FDA's definition for this code reads: "Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission...". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
NLQ
Device name
Single-Use Reprocessed Ultrasonic Surgical Instruments
FDA definition
Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). 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).
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
27
Ingested recalls
7

Clearances, product code NLQ

By decision year
27 clearances under product code NLQ with a decision year between 2001 and 2025, 2005 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NLQ by decision year
YearClearances
20011
20041
20054
20091
20102
20121
20143
20152
20161
20173
20181
20192
20201
20211
20242
20251

Applicants with the most clearances

Product code NLQ

Companies listing this code with FDA

Companies whose registered establishments list this code