510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952363Substantially Equivalent

Opus Pacemakers (Models 4021, 4033, and 4034)

Ela Medical, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952363 is the FDA 510(k) clearance record for OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034), a class I device, cleared for Ela Medical, Inc. on under FDA product code ELA (Instrument, Hand, Calculus Removal). FDA records list 43 510(k) clearances for Ela Medical, Inc., from to . As of , FDA records show no recalls naming K952363.

Clearance record

Decision date
Received
(106 days to decision)
Product code
ELA Instrument, Hand, Calculus Removal
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Ela Medical, Inc. 15245 Minnetonka Blvd., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code ELA

Trailing 12 months

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

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