510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935517Substantially Equivalent

Snap Sternum Saw

Surgiquip, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935517 is the FDA 510(k) clearance record for SNAP STERNUM SAW, a class I device, cleared for Surgiquip, Inc. on under FDA product code HAB (Saw, Powered, And Accessories). FDA records list 5 510(k) clearances for Surgiquip, Inc., from to . As of , FDA records show no recalls naming K935517.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HAB Saw, Powered, And Accessories
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgiquip, Inc. Regulatory Consultants, Dallas TX
510(k) summary
Summary
Third party review
No

Clearances, product code HAB

Trailing 12 months

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

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