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510(k) K221767

Surgical Sutures with or without Needle by Huaian Seamen Medical Technology Co., Ltd. — Product Code GAP

K221767 is an FDA 510(k) premarket notification submitted by Huaian Seamen Medical Technology Co., Ltd. for the device "Surgical Sutures with or without Needle". The FDA issued a decision of Substantially Equivalent on July 31, 2023. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2023
Date Received
June 17, 2022
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 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)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • 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