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Single-Use Reprocessed Ultrasonic Surgical Instruments

NLQ · Unclassified · Unknown

Classification

FDA Product Code
NLQ
Device class
Unclassified
Regulation
Review panel
SU
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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).

Market data

Cleared 510(k) submissions
27
Registered establishments
12

Source

Authoritative
FDA Device Classification database
Machine
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