510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943583Substantially Equivalent

Kerrison Rongeurs

Enterprise Medical Corp., Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943583 is the FDA 510(k) clearance record for KERRISON RONGEURS, a class II device, cleared for Enterprise Medical Corp. on under FDA product code HAE (Rongeur, Manual). FDA records list 3 510(k) clearances for Enterprise Medical Corp., from to . As of , FDA records show no recalls naming K943583.

Clearance record

Decision date
Received
(214 days to decision)
Product code
HAE Rongeur, Manual
Regulation
21 CFR 882.4840
Device class
Class II
Review panel
Neurology
Applicant
Enterprise Medical Corp. 3214 Brassfield Rd., #2201, Greensboro NC
510(k) summary
Statement
Third party review
No

Clearances, product code HAE

Trailing 12 months
1 clearance under product code HAE in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAE, 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 20261
October 20260