510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885066Substantially Equivalent

Hematome System

Surgical Dynamics Ltd, San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885066 is the FDA 510(k) clearance record for HEMATOME SYSTEM, a class I device, cleared for Surgical Dynamics, Inc. on under FDA product code GET (Motor, Surgical Instrument, Pneumatic Powered). FDA records list 12 510(k) clearances for Surgical Dynamics, Inc., from to . As of , FDA records show no recalls naming K885066.

Clearance record

Decision date
Received
(146 days to decision)
Product code
GET Motor, Surgical Instrument, Pneumatic Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgical Dynamics, Inc. 650 Whitney St., San Leandro CA
Third party review
No

Clearances, product code GET

Trailing 12 months

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

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