510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971853Substantially Equivalent

Endoview Spphire Lens Set

American Medical Devices, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971853 is the FDA 510(k) clearance record for ENDOVIEW SPPHIRE LENS SET, a class II device, cleared for American Medical Devices, Inc. on under FDA product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic). FDA records list 6 510(k) clearances for American Medical Devices, Inc., from to . As of , FDA records show no recalls naming K971853.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation
21 CFR 886.1385
Device class
Class II
Review panel
Ophthalmic
Applicant
American Medical Devices, Inc. 1100 Northside Dr., Atlanta GA
510(k) summary
Summary
Third party review
No

Clearances, product code HJK

Trailing 12 months

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

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