510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823835Substantially Equivalent

Spembly 140 Cryosystem Probes & Tips

Keller Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823835 is the FDA 510(k) clearance record for SPEMBLY 140 CRYOSYSTEM PROBES & TIPS, a class II device, cleared for Keller Instruments, Inc. on under FDA product code HQA (Unit, Cryotherapy, Ophthalmic). FDA records list 5 510(k) clearances for Keller Instruments, Inc., from to . As of , FDA records show no recalls naming K823835.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HQA Unit, Cryotherapy, Ophthalmic
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Keller Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HQA

Trailing 12 months

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

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