510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993851Substantially Equivalent

Sodem Perforator Drive

Sodemsystems, Geneva, Switzerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993851 is the FDA 510(k) clearance record for SODEM PERFORATOR DRIVE, a class II device, cleared for Sodemsystems on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list 8 510(k) clearances for Sodemsystems, from to . As of , FDA records show no recalls naming K993851.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Sodemsystems 110, Ch. Du Pont-Du-Centenaire, Geneva, Switzerland, CH
510(k) summary
Summary
Third party review
No

Clearances, product code HBB

Trailing 12 months
1 clearance under product code HBB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260