510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821358Substantially Equivalent

Modified Rongeurs for Spinal & Orth. S.

Downs Surgical, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821358 is the FDA 510(k) clearance record for MODIFIED RONGEURS FOR SPINAL & ORTH. S., a class I device, cleared for Downs Surgical , Ltd. on under FDA product code EMH (Forceps, Rongeur, Surgical). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K821358.

Clearance record

Decision date
Received
(22 days to decision)
Product code
EMH Forceps, Rongeur, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Downs Surgical , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EMH

Trailing 12 months

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

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