510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013151Substantially Equivalent

Asmotom Automated Trephine System

Bkg Opthalmics USA, Inc., Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013151 is the FDA 510(k) clearance record for ASMOTOM AUTOMATED TREPHINE SYSTEM, a class I device, cleared for Bkg Opthalmics USA, Inc. on under FDA product code HRG (Engine, Trephine, Accessories, Ac-Powered). FDA records list one 510(k) clearance for Bkg Opthalmics USA, Inc. As of , FDA records show no recalls naming K013151.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HRG Engine, Trephine, Accessories, Ac-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Bkg Opthalmics USA, Inc. 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary
Third party review
No

Clearances, product code HRG

Trailing 12 months

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

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