510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904869Substantially Equivalent

Ellipse Punch

Kramer Const, Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904869 is the FDA 510(k) clearance record for ELLIPSE PUNCH, a class I device, cleared for Kramer Const on under FDA product code LRY (Punch, Surgical). FDA records list one 510(k) clearance for Kramer Const. As of , FDA records show no recalls naming K904869.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LRY Punch, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kramer Const 819 University Avenure, Palo Alto CA
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