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
K893121Substantially Equivalent

Robotrac (Tm) Retractor Arm

Aesculap Instruments Corp., Burlingame CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893121 is the FDA 510(k) clearance record for ROBOTRAC (TM) RETRACTOR ARM, a class I device, cleared for Aesculap Instruments Corp. on under FDA product code GAD (Retractor). FDA records list 13 510(k) clearances for Aesculap Instruments Corp., from to . As of , FDA records show no recalls naming K893121.

Clearance record

Decision date
Received
(37 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Aesculap Instruments Corp. 875 Stanton Rd., Burlingame CA
Third party review
No

Clearances, product code GAD

Trailing 12 months

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

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