510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932591Substantially Equivalent

Endo-Judge

Synergistic Medical Technologies, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932591 is the FDA 510(k) clearance record for ENDO-JUDGE, a class I device, cleared for Synergistic Medical Technologies, Inc. on under FDA product code GAB (Needle, Suturing, Disposable). FDA records list one 510(k) clearance for Synergistic Medical Technologies, Inc. As of , FDA records show no recalls naming K932591.

Clearance record

Decision date
Received
(208 days to decision)
Product code
GAB Needle, Suturing, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Synergistic Medical Technologies, Inc. C/O Hogan & Hartson, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code GAB

Trailing 12 months

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

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