510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931792Substantially Equivalent

Arthroscope

Intramed Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931792 is the FDA 510(k) clearance record for ARTHROSCOPE, a class I device, cleared for Intramed Laboratories, Inc. on under FDA product code HRH (Trephine, Manual, Ophthalmic). FDA records list 14 510(k) clearances for Intramed Laboratories, Inc., from to . As of , FDA records show no recalls naming K931792.

Clearance record

Decision date
Received
(427 days to decision)
Product code
HRH Trephine, Manual, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Intramed Laboratories, Inc. 11100 Roselle St., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code HRH

Trailing 12 months

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

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