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510(k) K180701

SafePath Suturing System by Safepath Medical, Inc. — Product Code GAP

K180701 is an FDA 510(k) premarket notification submitted by Safepath Medical, Inc. for the device "SafePath Suturing System". The FDA issued a decision of Substantially Equivalent on June 25, 2018. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Safepath Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2018
Date Received
March 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

Other clearances by Safepath Medical, Inc.

  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)
  • K053638 — MANI NEEDLE & SUTURE PACK (SILK) (May 19, 2006)

FDA data resources