Non absorbable Surgical Silk Suture
K-Number: K232355 · 2024-01-16
Decision Date2024-01-16
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Non absorbable Surgical Silk Suture is a medical device manufactured by Shandong Haidike Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2024-01-16 under approval number K232355. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Non absorbable Surgical Silk Suture?
Non absorbable Surgical Silk Suture is a medical device that received FDA 510(k) clearance on 2024-01-16. It is manufactured by Shandong Haidike Medical Product Co., Ltd.. The 510(k) number is K232355.
When was Non absorbable Surgical Silk Suture approved by the FDA?
Non absorbable Surgical Silk Suture received FDA 510(k) clearance on 2024-01-16, under approval number K232355.
What company makes Non absorbable Surgical Silk Suture?
Non absorbable Surgical Silk Suture is manufactured by Shandong Haidike Medical Product Co., Ltd..
What is the FDA product code for Non absorbable Surgical Silk Suture?
The FDA product code for Non absorbable Surgical Silk Suture is GAP.
Related Clinical Trials
NCT06511414
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure
ACTIVE_NOT_RECRUITING
NCT07489820
Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
NOT_YET_RECRUITING
NCT07574086
Stratafix vs. PDS (Fascial Closure RCT)
NOT_YET_RECRUITING
NCT05261425
Suture Closure Trial
COMPLETED
NCT07019662
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
RECRUITING
NCT07498361
Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.
RECRUITING
Other Devices by Shandong Haidike Medical Product Co., Ltd.
Related Devices (Code: GAP)
K162396SILK Surgical SutureTeleflexmedical, Inc.
K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.
K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.
K180701SafePath Suturing SystemSafepath Medical, Inc.
K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.
K241486Sofsilk Coated Braided Silk SutureCovidien
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.