510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902636Substantially Equivalent

Lipogen Rheumelisa Dsdna Assay

Lipogen, Inc., Knoxville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902636 is the FDA 510(k) clearance record for LIPOGEN RHEUMELISA DSDNA ASSAY, a class I device, cleared for Lipogen, Inc. on under FDA product code LRY (Punch, Surgical). FDA records list 15 510(k) clearances for Lipogen, Inc., from to . As of , FDA records show no recalls naming K902636.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LRY Punch, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Lipogen, Inc. 10515 Research Dr., Knoxville TN
Third party review
No

Clearances, product code LRY

Trailing 12 months

FDA records hold no clearances under product code LRY in the trailing twelve months.

FDA records show no clearances under product code LRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260