510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K972057Substantially Equivalent

Powertrek Instruments

Medtrek Corp., Branford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972057 is the FDA 510(k) clearance record for POWERTREK INSTRUMENTS, a class II device, cleared for Medtrek Corp. on under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece). FDA records list one 510(k) clearance for Medtrek Corp. As of , FDA records show no recalls naming K972057.

Clearance record

Decision date
Received
(156 days to decision)
Product code
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation
21 CFR 874.4250
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Medtrek Corp. 1204 Main St., Suite 224, Branford CT
510(k) summary
Statement
Third party review
No

Clearances, product code ERL

Trailing 12 months

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

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