510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980686Substantially Equivalent

Aesculap Hilan Motor System

Aesculap Inc, South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980686 is the FDA 510(k) clearance record for AESCULAP HILAN MOTOR SYSTEM, a class II device, cleared for Aesculap, Inc. on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K980686.

Clearance record

Decision date
Received
(191 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 1000 Gateway Blvd., South San Francisco CA
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 November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260