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
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K180701Substantially Equivalent

SafePath Suturing System

Safepath Medical, Inc., Amesbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180701 is the FDA 510(k) clearance record for SafePath Suturing System, a class II device, cleared for Safepath Medical, Inc. on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 2 510(k) clearances for Safepath Medical, Inc., from to . As of , FDA records show no recalls naming K180701.

Clearance record

Decision date
Received
(101 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Safepath Medical, Inc. 21 Water St. - 5th Floor, Amesbury MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAP

Trailing 12 months

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

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