510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881151Substantially Equivalent

Microscrape

Ortho Pharmaceutical Corp., Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881151 is the FDA 510(k) clearance record for MICROSCRAPE, a class I device, cleared for Ortho Pharmaceutical Corp. on under FDA product code LXK (Scrapper, Skin Specimen). FDA records list 9 510(k) clearances for Ortho Pharmaceutical Corp., from to . As of , FDA records show no recalls naming K881151.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LXK Scrapper, Skin Specimen
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ortho Pharmaceutical Corp. Rte. 202, P.O. Box 300, Raritan NJ
Third party review
No

Clearances, product code LXK

Trailing 12 months

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

FDA records show no clearances under product code LXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXK, 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